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CompletedNCT01692301Updated May 4, 2016Results posted

Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension

A Phase 2 interventional study of LCZ696 and Olmesartan in Hypertension, sponsored by Novartis Pharmaceuticals. Completed at 47 sites in 12 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-05-04.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
454
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).

02

Conditions studied

  • Hypertension

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Keywords

  • hypertension, elderly, central aortic pulse pressure, central pulse pressure, pulse wave velocity
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 454 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Male and female patients ≥ 60 years of age.
  2. Patients with essential hypertension, untreated or currently taking antihypertensive therapy.
  3. Untreated patients must have an office msSBP ≥150 mmHg and \<180 mmHg at Visit 101 and Visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
  4. Treated patients must have an office msSBP ≥140 mmHg and \<180 mmHg at Visit 102 (or Visit 103) and msSBP ≥150 mmHg and \<180 mmHg at Visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to Visit 1.
  5. All patients must have pulse pressure >60 mmHg at Visit 201. Pulse pressure is defined as msSBP- msDBP.
  6. Patients must have a difference in msSBP within +/-15 mmHg between Visit 201 (randomization) and the visit immediately prior to Visit 201.

Key Exclusion Criteria:

  1. Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
  2. History of angioedema, drug-related or otherwise.
  3. History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
  4. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.
  5. History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
  6. History of atrial fibrillation or atrial flutter during the 3 months prior to Visit 1, or active atrial fibrillation or atrial flutter on the ECG at screening.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
454 participants (actual)

Study arms

  • Experimental
    LCZ696 (sacubitril/valsartan)

    Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.

    Drug: LCZ696 · Drug: LCZ696 matching placebo · Drug: Olmesartan matching placebo · Drug: amlodipine · Drug: hydrochlorothiazide

  • Active comparator
    Olmesartan

    Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.

    Drug: Olmesartan · Drug: LCZ696 matching placebo · Drug: amlodipine · Drug: hydrochlorothiazide

Interventions

  • DrugLCZ696

    200 mg tablet

    Also known as: sacubitril/valsartan

  • DrugOlmesartan

    20 mg and 40 mg capsules

  • DrugLCZ696 matching placebo

    LCZ696 Matching Placebo tablet

  • DrugOlmesartan matching placebo

    Olmesartan matching placebo capsule

  • Drugamlodipine

    amlodipine 2.5 mg or 5 mg tablets

  • Drughydrochlorothiazide

    hydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks

    Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software. At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits.

    Time frame: baseline, 12 weeks

Secondary outcomes

  1. Change From Baseline in Mean Central Pulse (CPP) Pressure

    Time frame: Baseline, 12 weeks, and 52 weeks

  2. Change From Baseline in Mean Pulse Wave Velocity (PWV)

    Pulse wave velocity recordings were performed on patient while in a supine, face-up position. Tonometry was performed on the carotid simultaneously with the cuff inflation over the femoral artery. Two pulse wave velocity measures, meeting all quality control criteria were captured at baseline, week 12 and week 52.

    Time frame: baseline, 12 weeks, and 52 weeks

  3. Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks

    Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software. At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits.

    Time frame: baseline, 52 weeks

  4. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

    At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.

    Time frame: baseline, 12 weeks, and 52 weeks

  5. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

    At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.

    Time frame: baseline, 12 weeks, and 52 weeks

  6. Change From Baseline in Mean Sitting Pulse Pressure (msPP)

    Mean sitting pulse pressure for each patient and visit was calculated as the difference between the calculated values of mean sitting systolic blood pressure and mean sitting diastolic blood pressure.

    Time frame: baseline, 12 weeks, and 52 weeks

  7. Change From Baseline in Mean Arterial Pressure (MAP)

    Mean arterial pressure (MAP) was calculated from mean sitting systolic BP (msSBP) and mean sitting diastolic BP (msDBP) as (2 \* msDBP + msSBP)/3.

    Time frame: baseline, 12 weeks, and 52 weeks

  8. Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)

    An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maSBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.

    Time frame: Baseline, 12 weeks, and 52 weeks

  9. Change From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP)

    An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maDBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.

    Time frame: Baseline, 12 weeks, and 52 weeks

  10. Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP)

    Mean 24 hour ambulatory pulse pressure was calculated as the difference between the mean 24 hour systolic and diastolic ambulatory blood pressure in corresponding visits i.e. baseline, week 12 and week 52.

    Time frame: Baseline, 12 weeks, and 52 weeks

07

Results

Posted May 4, 2016

Participant flow

Participant flow — Overall Study
MilestoneLCZ696 (Sacubitril/Valsartan)Olmesartan
Started229225
Completed184183
Not completed4542
Withdrew: Adverse event1512
Withdrew: Death12
Withdrew: Lack of efficacy05
Withdrew: Non-compliance with study treatment12
Withdrew: Protocol deviation92
Withdrew: Patient/guardian decision1615
Withdrew: Technical problems01
Withdrew: Physician decision22
Withdrew: Lost to follow-up11

Outcome measures

PrimaryChange From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks

Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software. At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits.

Time frame:
baseline, 12 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks
mmHgLCZ696 (Sacubitril/Valsartan)Olmesartan
Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks-12.57 ± 1.01-8.90 ± 1.01
Statistical analysis
  • LCZ696 (Sacubitril/Valsartan) vs Olmesartan · ANCOVA · p = 0.010 · Mean difference (net): -3.66 · 95% CI -6.45 to -0.87
SecondaryChange From Baseline in Mean Central Pulse (CPP) Pressure
Time frame:
Baseline, 12 weeks, and 52 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean Central Pulse (CPP) Pressure
mmHgLCZ696 (Sacubitril/Valsartan)Olmesartan
Baseline to Week 12 (n = 207, 206)-6.41 ± 0.69-3.96 ± 0.69
Baseline to Week 52 (n = 209, 208)-7.16 ± 0.69-6.65 ± 0.69
SecondaryChange From Baseline in Mean Pulse Wave Velocity (PWV)

Pulse wave velocity recordings were performed on patient while in a supine, face-up position. Tonometry was performed on the carotid simultaneously with the cuff inflation over the femoral artery. Two pulse wave velocity measures, meeting all quality control criteria were captured at baseline, week 12 and week 52.

Time frame:
baseline, 12 weeks, and 52 weeks
Reported as:
Least squares mean · meter/second
Change From Baseline in Mean Pulse Wave Velocity (PWV)
meter/secondLCZ696 (Sacubitril/Valsartan)Olmesartan
Baseline to week 12 (n= 192, 196)-0.68 ± 0.12-0.57 ± 0.12
Baseline to week 52 ( n= 199, 199)-0.83 ± 0.130.77 ± 0.13
SecondaryChange From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks

Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software. At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits.

Time frame:
baseline, 52 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks
mmHgLCZ696 (Sacubitril/Valsartan)Olmesartan
Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks-16.18 ± 0.96-14.70 ± 0.96
SecondaryChange From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.

Time frame:
baseline, 12 weeks, and 52 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
mmHgLCZ696 (Sacubitril/Valsartan)Olmesartan
Baseline to week 12 (n=226, 222)-20.84 ± 1.06-14.57 ± 1.07
Baseline to week 52 (n=226,223)-23.91 ± 0.98-21.45 ± 0.99
SecondaryChange From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.

Time frame:
baseline, 12 weeks, and 52 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
mmHgLCZ696 (Sacubitril/Valsartan)Olmesartan
Baseline to week 12 (n=226, 222)-7.86 ± 0.58-5.58 ± 0.59
Baseline to week 52 (n=226,223)-8.92 ± 0.57-7.85 ± 0.57
SecondaryChange From Baseline in Mean Sitting Pulse Pressure (msPP)

Mean sitting pulse pressure for each patient and visit was calculated as the difference between the calculated values of mean sitting systolic blood pressure and mean sitting diastolic blood pressure.

Time frame:
baseline, 12 weeks, and 52 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean Sitting Pulse Pressure (msPP)
mmHgLCZ696 (Sacubitril/Valsartan)Olmesartan
Baseline to week 12 (n=226,222)-13.13 ± 0.82-8.86 ± 0.82
Baseline to week 52 (n= 226, 223)-15.02 ± 0.79-13.58 ± 0.80
SecondaryChange From Baseline in Mean Arterial Pressure (MAP)

Mean arterial pressure (MAP) was calculated from mean sitting systolic BP (msSBP) and mean sitting diastolic BP (msDBP) as (2 \* msDBP + msSBP)/3.

Time frame:
baseline, 12 weeks, and 52 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean Arterial Pressure (MAP)
mmHgLCZ696 (Sacubitril/Valsartan)Olmesartan
Baseline to week 12 (n=226, 222)-12.19 ± 0.68-8.57 ± 0.68
Baseline to week 52 (n=226, 223)-13.92 ± 0.63-12.38 ± 0.64
SecondaryChange From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)

An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maSBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.

Time frame:
Baseline, 12 weeks, and 52 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)
mmHgLCZ696 (Sacubitril/Valsartan)Olmesartan
Baseline to week 12 (n= 164, 162)-13.25 ± 0.62-9.14 ± 0.62
Baseline to week 52 (n= 174, 176)-14.15 ± 0.59-14.32 ± 0.58
SecondaryChange From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP)

An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maDBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.

Time frame:
Baseline, 12 weeks, and 52 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP)
mmHgLCZ696 (Sacubitril/Valsartan)Olmesartan
Baseline to week 12 (n= 164, 162)-7.44 ± 0.37-5.48 ± 0.36
Baseline to week 52 (n= 174, 176)-8.85 ± 0.35-8.44 ± 0.34
SecondaryChange From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP)

Mean 24 hour ambulatory pulse pressure was calculated as the difference between the mean 24 hour systolic and diastolic ambulatory blood pressure in corresponding visits i.e. baseline, week 12 and week 52.

Time frame:
Baseline, 12 weeks, and 52 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP)
mmHgLCZ696 (Sacubitril/Valsartan)Olmesartan
Baseline to Week 12 (n=164, 162 )-5.77 ± 0.35-3.69 ± 0.35
Baseline to week 52 (n=174, 176)-5.26 ± 0.36-5.91 ± 0.35

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LCZ696 (Sacubitril/Valsartan)—16/229 (7%)73/229 (31.9%)
Olmesartan—13/225 (5.8%)55/225 (24.4%)
Most frequent serious events
Showing 10 of 39
Most frequent serious events
EventLCZ696 (Sacubitril/Valsartan)Olmesartan
RIB FRACTUREInjury, poisoning and procedural complications0/2292/225
ATRIAL FIBRILLATIONCardiac disorders2/2291/225
ACUTE CORONARY SYNDROMECardiac disorders0/2291/225
ACUTE MYOCARDIAL INFARCTIONCardiac disorders0/2291/225
ANGINA PECTORISCardiac disorders0/2291/225
ANGINA UNSTABLECardiac disorders0/2291/225
CARDIO-RESPIRATORY ARRESTCardiac disorders0/2291/225
HIP FRACTUREInjury, poisoning and procedural complications0/2291/225
PULMONARY CONTUSIONInjury, poisoning and procedural complications0/2291/225
SPINAL FRACTUREInjury, poisoning and procedural complications0/2291/225
Most frequent other events
Showing 10 of 13
Most frequent other events
EventLCZ696 (Sacubitril/Valsartan)Olmesartan
NASOPHARYNGITISInfections and infestations16/22912/225
HEADACHENervous system disorders14/22910/225
DIZZINESSNervous system disorders12/22912/225
BACK PAINMusculoskeletal and connective tissue disorders3/22910/225
COUGHRespiratory, thoracic and mediastinal disorders10/2292/225
ARTHRALGIAMusculoskeletal and connective tissue disorders5/2297/225
INFLUENZAInfections and infestations7/2295/225
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations6/2296/225
DIARRHOEAGastrointestinal disorders6/2295/225
OEDEMA PERIPHERALGeneral disorders6/2292/225

Baseline characteristics

Full analysis set - All patients who were randomized.

Age, Continuous
Age, Continuous(Years)LCZ696 (Sacubitril/Valsartan)OlmesartanTotal
Mean68.2 ± 5.7367.2 ± 5.9767.7 ± 5.87
Sex: Female, Male
Sex: Female, Male(Participants)LCZ696 (Sacubitril/Valsartan)OlmesartanTotal
Female110107217
Male119118237
08

Study locations

47 sites
  • Novartis Investigative Site
    Clearwater, Florida 33756, United States
  • Novartis Investigative Site
    Chicago, Illinois 60607, United States
  • Novartis Investigative Site
    Baltimore, Maryland 21204, United States
  • Novartis Investigative Site
    Belzoni, Mississippi 39038, United States
  • Novartis Investigative Site
    Jackson, Mississippi 39209, United States
  • Novartis Investigative Site
    St. Louis, Missouri 63141, United States
  • Novartis Investigative Site
    Buffalo, New York 14215, United States
  • Novartis Investigative Site
    Cincinnati, Ohio 45224, United States
  • Novartis Investigative Site
    Houston, Texas 77081, United States
  • Novartis Investigative Site
    Lake Jackson, Texas 77566, United States
  • Novartis Investigative Site
    Pasadena, Texas 77504, United States
  • Novartis Investigative Site
    Caba, Buenos Aires C1440AAD, Argentina
  • Novartis Investigative Site
    Ramos Mejia, Buenos Aires B1704ETD, Argentina
  • Novartis Investigative Site
    Rosario, Santa Fe S2000CXH, Argentina
  • Novartis Investigative Site
    Barranquilla, Atlantico, Colombia
  • Novartis Investigative Site
    Barranquilla, Colombia
  • Novartis Investigative Site
    Paris, 75015, France
  • Novartis Investigative Site
    Berlin, 10117, Germany
  • Novartis Investigative Site
    Nuernberg, 90471, Germany
  • Novartis Investigative Site
    Athens, 11525, Greece
  • Novartis Investigative Site
    Athens, 11526, Greece
  • Novartis Investigative Site
    Thessaloniki, 54642, Greece
  • Novartis Investigative Site
    Treviglio, BG 24047, Italy
  • Novartis Investigative Site
    Pisa, PI 56126, Italy
  • Novartis Investigative Site
    San Daniele Del Friuli, UD 33038, Italy
  • Novartis Investigative Site
    Shimotsuke-city, Tochigi 329-0498, Japan
  • Novartis Investigative Site
    Bucheon, Gyeonggi-do 424-717, Korea, Republic of
  • Novartis Investigative Site
    Seoul, Korea 110 744, Korea, Republic of
  • Novartis Investigative Site
    Moscow, 101990, Russian Federation
  • Novartis Investigative Site
    Moscow, 117198, Russian Federation
  • Novartis Investigative Site
    Moscow, 119992, Russian Federation
  • Novartis Investigative Site
    Saint Petersburg, 197022, Russian Federation
  • Novartis Investigative Site
    Saint-Petersburg, 197341, Russian Federation
  • Novartis Investigative Site
    Yaroslavl, 150047, Russian Federation
  • Novartis Investigative Site
    Sevilla, Andalucia 41071, Spain
  • Novartis Investigative Site
    Jerez de La Frontera, Cadiz 11407, Spain
  • Novartis Investigative Site
    Barcelona, Cataluna 08003, Spain
  • Novartis Investigative Site
    Barcelona, Catalunya 08025, Spain
  • Novartis Investigative Site
    Terrassa, Catalunya 08221, Spain
  • Novartis Investigative Site
    Centelles, Cataluña 08540, Spain
  • Novartis Investigative Site
    Puerto de Sagunto, Comunidad Valenciana 46520, Spain
  • Novartis Investigative Site
    La Coruna, Galicia 15706, Spain
  • Novartis Investigative Site
    Madrid, 28034, Spain
  • Novartis Investigative Site
    Madrid, 28041, Spain
  • Novartis Investigative Site
    Taipei, Taiwan, ROC 112, Taiwan
  • Novartis Investigative Site
    Taichung, 40447, Taiwan
  • Novartis Investigative Site
    Taipei, 114, Taiwan
09

References and documents

Publications

  • Williams B, Cockcroft JR, Kario K, Zappe DH, Cardenas P, Hester A, Brunel P, Zhang J. Rationale and study design of the Prospective comparison of Angiotensin Receptor neprilysin inhibitor with Angiotensin receptor blocker MEasuring arterial sTiffness in the eldERly (PARAMETER) study. BMJ Open. 2014 Feb 4;4(2):e004254. doi: 10.1136/bmjopen-2013-004254. PubMed 24496699 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01692301
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 25, 2012
Start date
Dec 2012
Primary completion
Apr 2015
Completion
Apr 2015
Results posted
May 4, 2016
Last update
May 4, 2016

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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