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CompletedNCT00549770Updated Aug 25, 2015Results posted

Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

A Phase 2 interventional study of LCZ696 and Valsartan in Hypertension, sponsored by Novartis Pharmaceuticals. Completed at 182 sites in 18 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-08-25.

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

Phase
Phase 2
Study type
Interventional
Enrollment
1,334
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.

02

Conditions studied

  • Hypertension

Keywords

  • Hypertension, valsartan, LCZ696
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 1,334 is above the median of 90 across 4,994 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
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or females from 18 up to and including 75 years
  • Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs; therapy with a fixed dose combination of two active substances represents 2 drugs)
  • Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2).
  • Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP> 95 mmHg at baseline (Visit 3);

Exclusion criteria

Exclusion Criteria:

  • Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg)
  • History of angioedema, drug-related or otherwise, as reported by the patient
  • Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)
  • History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc.
  • History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,334 participants (actual)

Study arms

  • Experimental
    LCZ696 100 mg

    Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

    Drug: LCZ696 · Drug: Placebo

  • Experimental
    LCZ696 200 mg

    Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

    Drug: LCZ696 · Drug: Placebo

  • Experimental
    LCZ696 400 mg

    Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

    Drug: LCZ696 · Drug: Placebo

  • Active comparator
    Valsartan 80 mg

    Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

    Drug: Valsartan · Drug: Placebo

  • Active comparator
    Valsartan 160 mg

    Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsatan and AHU377 (5 tablets and 2 capsules) daily.

    Drug: Valsartan · Drug: Placebo

  • Active comparator
    Valsartan 320 mg

    Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

    Drug: Valsartan · Drug: Placebo

  • Experimental
    AHU377 200 mg

    Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.

    Drug: AHU377 · Drug: Placebo

  • Placebo comparator
    Placebo

    Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

    Drug: Placebo

Interventions

  • DrugLCZ696
  • DrugValsartan
  • DrugAHU377
  • DrugPlacebo
06

What researchers measure

Primary outcomes

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

    Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.

    Time frame: baseline, week 8

Secondary outcomes

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

    Sitting BP measurements were performed at screening through the end of the study at every study visit.

    Time frame: baseline, week 8

  2. Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP

    Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8.

    Time frame: baseline, 8 weeks

  3. Change From Baseline in Daytime maDBP and maSBP

    Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the avergae of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm.

    Time frame: baseline, 8 weeks

  4. Change From Baseline in Nighttime maDBP and maSBP

    Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am.

    Time frame: baseline, 8 weeks

  5. Percentage of Participants Who Achieved a Successful Response in msDBP

    Successful response in msDBP is defined as msDBP \<90 mmHg or a reduction ≥ 10 mmHg from baseline.

    Time frame: 8 weeks

  6. Percentage of Participants Who Achieved a Successful Response in msSBP

    Successful response in msSBP is defined as msSBP \<140 mmHg or a reduction ≥ 20 mmHg from baseline.

    Time frame: 8 weeks

  7. Percentage of Participants Who Achieved Successful Control in msDBP

    Successful control in msDBP is defined as msDBP \<90 mmHg.

    Time frame: 8 weeks

  8. Percentage of Participants Who Achieved Successful Control in msSBP

    Successful control in msSBP is defined as \<140 mmHg.

    Time frame: 8 weeks

07

Results

Posted Aug 10, 2015

Participant flow

The study comprised 3 periods: a 4-week washout and placebo run-in period (pre-randomization), an 8-week randomized, double-blind monotherapy period, and 1-week randomized, placebo-controlled withdrawal period. In the randomized withdrawal, participants were either randomized to placebo or continued their original assigned treatment.

Participant flow — Overall Study
MilestoneLCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlacebo
Started156169172163166164165173
Intent-to-treat population154168170163163163164172
Ambulatory blood pressure monitoring4861535549545057
Completed149158162147149151151148
Not completed711101617131425
Withdrew: Protocol deviation11122212
Withdrew: Administrative problems01000001
Withdrew: Lost to follow-up00223200
Withdrew: Withdrawal by subject46456649
Withdrew: Lack of efficacy10235138
Withdrew: Abnormal test procedure results00020111
Withdrew: Abnormal laboratory values00000100
Withdrew: Adverse event13121054

Outcome measures

PrimaryChange From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.

Time frame:
baseline, week 8
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
mmHgLCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlacebo
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)-9.97 ± 0.73-12.92 ± 0.70-13.63 ± 0.70-9.14 ± 0.72-9.95 ± 0.71-10.93 ± 0.71-9.76 ± 0.71-6.78 ± 0.69
SecondaryChange From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

Sitting BP measurements were performed at screening through the end of the study at every study visit.

Time frame:
baseline, week 8
Reported as:
Least squares mean · mmHg
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
mmHgLCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlacebo
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)-13.75 ± 1.15-18.70 ± 1.10-20.17 ± 1.10-12.44 ± 1.12-13.42 ± 1.12-14.16 ± 1.12-11.93 ± 1.11-7.72 ± 1.09
SecondaryChange From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP

Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8.

Time frame:
baseline, 8 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP
mmHgLCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlacebo
maDBP-3.80 ± 0.72-6.78 ± 0.64-8.32 ± 0.71-4.56 ± 0.67-6.25 ± 0.70-7.13 ± 0.67-3.67 ± 0.70-1.33 ± 0.67
maSBP-7.80 ± 1.04-11.50 ± 0.93-14.56 ± 1.03-7.29 ± 0.96-8.27 ± 1.00-9.42 ± 0.97-5.18 ± 1.02-2.90 ± 0.96
SecondaryChange From Baseline in Daytime maDBP and maSBP

Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the avergae of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm.

Time frame:
baseline, 8 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Daytime maDBP and maSBP
mmHgLCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlacebo
maDBP-4.05 ± 1.23-6.91 ± 1.12-7.80 ± 1.19-4.78 ± 1.17-7.40 ± 1.23-7.47 ± 1.17-3.18 ± 1.22-1.53 ± 1.14
maSBP-7.96 ± 1.73-11.76 ± 1.58-14.20 ± 1.67-7.59 ± 1.65-9.54 ± 1.73-9.90 ± 1.66-4.49 ± 1.72-3.40 ± 1.61
SecondaryChange From Baseline in Nighttime maDBP and maSBP

Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am.

Time frame:
baseline, 8 weeks
Reported as:
Least squares mean · mmHg
Change From Baseline in Nighttime maDBP and maSBP
mmHgLCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlacebo
maDBP-2.87 ± 1.25-7.73 ± 1.13-6.93 ± 1.23-4.04 ± 1.17-4.18 ± 1.24-6.17 ± 1.18-3.31 ± 1.24-1.01 ± 1.16
maSBP-6.40 ± 1.77-11.85 ± 1.60-12.04 ± 1.73-6.43 ± 1.66-5.82 ± 1.74-7.51 ± 1.67-3.99 ± 1.75-2.09 ± 1.63
SecondaryPercentage of Participants Who Achieved a Successful Response in msDBP

Successful response in msDBP is defined as msDBP \<90 mmHg or a reduction ≥ 10 mmHg from baseline.

Time frame:
8 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants Who Achieved a Successful Response in msDBP
Percentage of participantsLCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlacebo
Percentage of Participants Who Achieved a Successful Response in msDBP53.9069.6474.1251.5355.8363.1954.2739.53
SecondaryPercentage of Participants Who Achieved a Successful Response in msSBP

Successful response in msSBP is defined as msSBP \<140 mmHg or a reduction ≥ 20 mmHg from baseline.

Time frame:
8 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants Who Achieved a Successful Response in msSBP
Percentage of participantsLCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlacebo
Percentage of Participants Who Achieved a Successful Response in msSBP55.8463.6972.3551.5351.5357.0646.3437.79
SecondaryPercentage of Participants Who Achieved Successful Control in msDBP

Successful control in msDBP is defined as msDBP \<90 mmHg.

Time frame:
8 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants Who Achieved Successful Control in msDBP
Percentage of participantsLCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlacebo
Percentage of Participants Who Achieved Successful Control in msDBP47.4060.1265.8845.4047.8556.4446.9538.37
SecondaryPercentage of Participants Who Achieved Successful Control in msSBP

Successful control in msSBP is defined as \<140 mmHg.

Time frame:
8 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants Who Achieved Successful Control in msSBP
Percentage of participantsLCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlacebo
Percentage of Participants Who Achieved Successful Control in msSBP47.4056.5562.9445.4042.3353.3737.2031.98

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LCZ696 100 mg—1/156 (0.6%)4/156 (2.6%)
LCZ696 200 mg—0/169 (0%)4/169 (2.4%)
LCZ696 400 mg—1/172 (0.6%)4/172 (2.3%)
Valsartan 80 mg—1/163 (0.6%)5/163 (3.1%)
Valsartan 160 mg—0/166 (0%)4/166 (2.4%)
Valsartan 320 mg—0/164 (0%)3/164 (1.8%)
AHU377 200 mg—0/165 (0%)5/165 (3%)
Placebo—0/173 (0%)13/173 (7.5%)
Most frequent serious events
Most frequent serious events
EventLCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlacebo
Road traffic accidentInjury, poisoning and procedural complications1/1560/1690/1720/1630/1660/1640/1650/173
Upper limb fractureInjury, poisoning and procedural complications1/1560/1690/1720/1630/1660/1640/1650/173
Endometrial cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1560/1690/1721/1630/1660/1640/1650/173
Back painMusculoskeletal and connective tissue disorders0/1560/1691/1720/1630/1660/1640/1650/173
DyspnoeaRespiratory, thoracic and mediastinal disorders0/1560/1691/1720/1630/1660/1640/1650/173
Most frequent other events
Most frequent other events
EventLCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlacebo
HeadacheNervous system disorders4/1564/1694/1725/1634/1663/1645/16513/173

Baseline characteristics

Age, Continuous
Age, Continuous(years)LCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlaceboTotal
Mean53 ± 10.454 ± 9.752 ± 10.953 ± 9.653 ± 9.753 ± 10.153 ± 10.754 ± 10.653 ± 10.2
Sex: Female, Male
Sex: Female, Male(Participants)LCZ696 100 mgLCZ696 200 mgLCZ696 400 mgValsartan 80 mgValsartan 160 mgValsartan 320 mgAHU377 200 mgPlaceboTotal
Female6177756868657579568
Male9592979598999094760
08

Study locations

182 sites
  • Novartis Investigative Site
    Birmingham, Alabama 35294-2041, United States
  • Novartis Investigative Site
    Muscle Shoals, Alabama 35662, United States
  • Novartis Investigative Site
    Chandler, Arizona 85224, United States
  • Novartis Investigative Site
    Buena Park, California 90620, United States
  • Novartis Investigative Site
    Fair Oaks, California 95628, United States
  • Novartis Investigative Site
    Long Beach, California 90806, United States
  • Novartis Investigative Site
    Los Angeles, California 90057, United States
  • Novartis Investigative Site
    Orangevale, California 95662, United States
  • Novartis Investigative Site
    Santa Ana, California 92701, United States
  • Novartis Investigative Site
    Stockton, California 95204, United States
  • Novartis Investigative Site
    Tustin, California 92780, United States
  • Novartis Investigative Site
    Jacksonville, Florida 32216, United States
  • Novartis Investigative Site
    Pembroke Pines, Florida 33024, United States
  • Novartis Investigative Site
    Pembroke Pines, Florida 33029, United States
  • Novartis Investigative Site
    Pensacola, Florida 32504, United States
  • Novartis Investigative Site
    Augusta, Georgia 30904, United States
  • Novartis Investigative Site
    Chicago, Illinois 60607, United States
  • Novartis Investigative Site
    Chicago, Illinois 60610, United States
  • Novartis Investigative Site
    Peoria, Illinois 61615, United States
  • Novartis Investigative Site
    Baton Rouge, Louisiana 70809, United States
  • Novartis Investigative Site
    Metairie, Louisiana 70006, United States
  • Novartis Investigative Site
    Chelsea, Michigan 48118, United States
  • Novartis Investigative Site
    Royal Oak, Michigan 48073, United States
  • Novartis Investigative Site
    Brooklyn Center, Minnesota 55430-2168, United States
  • Novartis Investigative Site
    St. Peters, Missouri 63376, United States
  • Novartis Investigative Site
    Toms River, New Jersey 08753, United States
  • Novartis Investigative Site
    Trenton, New Jersey 08629, United States
  • Novartis Investigative Site
    Cincinnati, Ohio 45219, United States
  • Novartis Investigative Site
    Cincinnati, Ohio 45224, United States
  • Novartis Investigative Site
    Oklahoma City, Oklahoma 73132-4904, United States
  • Novartis Investigative Site
    Simpsonville, South Carolina 29681, United States
  • Novartis Investigative Site
    Dallas, Texas 75235, United States
  • Novartis Investigative Site
    Houston, Texas 77030-3411, United States
  • Novartis Investigative Site
    Houston, Texas 77081, United States
  • Novartis Investigative Site
    Houston, Texas 77083, United States
  • Novartis Investigative Site
    Lake Jackson, Texas 77566, United States
  • Novartis Investigative Site
    Richmond, Virginia 23294, United States
  • Novartis Investigative Site
    Charleston, West Virginia 25301, United States
  • Novartis Investigative Site
    Caba, Buenos Aires C1408INH, Argentina
  • Novartis Investigative Site
    Caba, Buenos Aires C1416DRJ, Argentina
  • Novartis Investigative Site
    Caba, Buenos Aires C1425AST, Argentina
  • Novartis Investigative Site
    Rosario, Santa Fe S2000CXH, Argentina
  • Novartis Investigative Site
    Corrientes, W3400, Argentina
  • Novartis Investigative Site
    Cambridge, Ontario N1R 6V6, Canada
  • Novartis Investigative Site
    Mississauga, Ontario M4T 4J2, Canada
  • Novartis Investigative Site
    Toronto, Ontario M9W 4L6, Canada
  • Novartis Investigative Site
    Granby, Quebec J2G 8Z9, Canada
  • Novartis Investigative Site
    Longueil, Quebec J4N 1L6, Canada
  • Novartis Investigative Site
    Montreal, Quebec H1T 2M4, Canada
  • Novartis Investigative Site
    Sherbrooke, Quebec J1J 2G2, Canada
  • Novartis Investigative Site
    Ste-Foy, Quebec G1V 4G2, Canada
  • Novartis Investigative Site
    Saskatoon, Saskatchewan S7H 5M3, Canada
  • Novartis Investigative Site
    Aalborg SV, 9200, Denmark
  • Novartis Investigative Site
    Aalborg, DK-9000, Denmark
  • Novartis Investigative Site
    Espergærde, 3060, Denmark
  • Novartis Investigative Site
    Greve, 2670, Denmark
  • Novartis Investigative Site
    Roslev, 7870, Denmark
  • Novartis Investigative Site
    Vaerloese, DK-3500, Denmark
  • Novartis Investigative Site
    Viborg, 8800, Denmark
  • Novartis Investigative Site
    Helsinki, 00180, Finland
  • Novartis Investigative Site
    Helsinki, 00350, Finland
  • Novartis Investigative Site
    Helsinki, 00810, Finland
  • Novartis Investigative Site
    Kerava, 04200, Finland
  • Novartis Investigative Site
    Oulu, 90100, Finland
  • Novartis Investigative Site
    Tampere, 33100, Finland
  • Novartis Investigative Site
    Bourges, 18000, France
  • Novartis Investigative Site
    La Chapelle sur Erdre, 44240, France
  • Novartis Investigative Site
    La Roche sur Yon, 85000, France
  • Novartis Investigative Site
    Le Pradet, 83220, France
  • Novartis Investigative Site
    Murs Erigné, 49610, France
  • Novartis Investigative Site
    Saint Avertin, 37550, France
  • Novartis Investigative Site
    Tours, 37000, France
  • Novartis Investigative Site
    Vihiers, 49310, France
  • Novartis Investigative Site
    Balve, 58802, Germany
  • Novartis Investigative Site
    Beckingen, 66701, Germany
  • Novartis Investigative Site
    Berlin, 10719, Germany
  • Novartis Investigative Site
    Berlin, 13053, Germany
  • Novartis Investigative Site
    Einbeck, 37574, Germany
  • Novartis Investigative Site
    Erfurt, 99084, Germany
  • Novartis Investigative Site
    Giengen, 89537, Germany
  • Novartis Investigative Site
    Hagen, 58095, Germany
  • Novartis Investigative Site
    Haigerloch, 72401, Germany
  • Novartis Investigative Site
    Hamburg, 22335, Germany
  • Novartis Investigative Site
    Kassel, 34125, Germany
  • Novartis Investigative Site
    Krefeld, 47798, Germany
  • Novartis Investigative Site
    Mahlberg, 77972, Germany
  • Novartis Investigative Site
    Messkirch, 88605, Germany
  • Novartis Investigative Site
    Reinfeld, 23858, Germany
  • Novartis Investigative Site
    Siegen, 57074, Germany
  • Novartis Investigative Site
    Wallerfing, 94574, Germany
  • Novartis Investigative Site
    Warendorf, 48231, Germany
  • Novartis Investigative Site
    Budapest, 1134, Hungary
  • Novartis Investigative Site
    Esztergom, 2500, Hungary
  • Novartis Investigative Site
    Miskolc, 3526, Hungary
  • Novartis Investigative Site
    Nyiregyháza, 4400, Hungary
  • Novartis Investigative Site
    Caserta, CE 81100, Italy
  • Novartis Investigative Site
    Cona, FE 44100, Italy
  • Novartis Investigative Site
    Firenze, FI 50134, Italy
  • Novartis Investigative Site
    Pozzilli, IS 86077, Italy
  • Novartis Investigative Site
    Rozzano, MI 20089, Italy

Showing the first 100 of 182 sites across 18 countries.

09

References and documents

Publications

  • Andersen MB, Simonsen U, Wehland M, Pietsch J, Grimm D. LCZ696 (Valsartan/Sacubitril)--A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):14-22. doi: 10.1111/bcpt.12453. Epub 2015 Sep 4. PubMed 26280447 ↗
  • Ruilope LM, Dukat A, Bohm M, Lacourciere Y, Gong J, Lefkowitz MP. Blood-pressure reduction with LCZ696, a novel dual-acting inhibitor of the angiotensin II receptor and neprilysin: a randomised, double-blind, placebo-controlled, active comparator study. Lancet. 2010 Apr 10;375(9722):1255-66. doi: 10.1016/S0140-6736(09)61966-8. Epub 2010 Mar 16. PubMed 20236700 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00549770
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 26, 2007
Start date
Sep 2007
Primary completion
Jul 2008
Completion
Jul 2008
Results posted
Aug 10, 2015
Last update
Aug 25, 2015

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
Novartis Pharmaceuticals
study chair · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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