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CompletedNCT00698646Updated Apr 19, 2011Results posted

Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.

A Phase 4 interventional study of Valsartan + HCTZ and Valsartan in Hypertension, sponsored by Novartis Pharmaceuticals. Completed at 20 sites in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2011-04-19.

Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
384
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension

02

Conditions studied

  • Hypertension

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Keywords

  • Systolic blood pressure
  • Diastolic blood pressure
  • Valsartan
  • Hydrochlorothiazide
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 384 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
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 70 years or older.
  • Patients with hypertension prior to being randomized into study.
  • Patients must have an office cuff MSSBP ≥ 140 and ≤ 200 mmHg systolic.
  • Have the ability to communicate and comply with all study requirements.
  • Provide written informed consent to participate in the study prior to any screening or study procedures.

Exclusion criteria

Exclusion Criteria:

  • Use of other investigational drugs within 30 days of enrollment.
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
  • Office blood pressure measured by office machine cuff with a mean of (3) MSDBP ≥ 120 mmHg at anytime during the screening / washout period.
  • Patients taking 3 or more antihypertensive drugs and MSSBP ≥ 160 mmHg at the time of Visit 1.
  • Other protocol-defined exclusion criteria may apply
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
384 participants (actual)

Study arms

  • Active comparator
    Valsartan

    (patients initiated on valsartan)

    Drug: Valsartan

  • Active comparator
    HCTZ

    (patients initiated on HCTZ)

    Drug: HCTZ

  • Experimental
    Valsartan + HCTZ

    (patients initiated on Valsartan+HCTZ)

    Drug: Valsartan + HCTZ

Interventions

  • DrugValsartan + HCTZ

    At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.

  • DrugValsartan

    At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.

  • DrugHCTZ

    At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.

06

What researchers measure

Primary outcomes

  1. Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)

    Time frame: Baseline and Week 4

Secondary outcomes

  1. Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)

    Time frame: Baseline and Weeks 4, 8, 12 and 16

  2. Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)

    Time frame: Baseline and Weeks 8, 12, and 16

  3. Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg

    Cumulative refers to achieving of blood pressure control before or at the corresponding visit.

    Time frame: Weeks 4, 8, 12 and 16

  4. Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)

    Cumulative refers to achieving blood pressure goal before or at the corresponding visit.

    Time frame: Weeks 4, 8, 12 and 16

  5. Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])

    Time frame: During 16 weeks

07

Results

Posted Dec 15, 2010

Participant flow

Participant flow — Overall Study
MilestoneValsartanHCTZValsartan + HCTZ
Started128128128
Completed929799
Not completed363129
Withdrew: Adverse event878
Withdrew: Unsatisfactory therapeutic effect11117
Withdrew: Protocol deviation623
Withdrew: Withdrawal by subject10118
Withdrew: Lost to follow-up002
Withdrew: Administrative problems101

Outcome measures

PrimaryChange From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Time frame:
Baseline and Week 4
Reported as:
Mean · mm Hg
Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
mm HgValsartanHCTZValsartan + HCTZ
Baseline166.2 ± 11.07164.5 ± 11.84164.5 ± 11.86
Week 4157.5 ± 19.71150.9 ± 18.41147.1 ± 18.35
Change in MSSBP from Baseline to Week 4-8.6 ± 19.47-13.6 ± 16.81-17.3 ± 17.61
SecondaryChange From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
Time frame:
Baseline and Weeks 4, 8, 12 and 16
Reported as:
Mean · mm Hg
Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
mm HgValsartanHCTZValsartan + HCTZ
Baseline84.9 ± 9.7885.5 ± 9.0984.8 ± 9.36
Week 481.0 ± 10.6181.6 ± 10.9777.8 ± 9.66
Change in MSDBP from Baseline to Week 4-3.9 ± 9.08-3.9 ± 10.24-7.1 ± 8.80
Week 878.3 ± 10.3379.1 ± 11.9776.5 ± 9.45
Change in MSDBP from Baseline to Week 8-6.6 ± 10.26-6.4 ± 10.72-8.4 ± 9.68
Week 1277.6 ± 11.078.1 ± 11.4275.4 ± 8.87
Change in MSDBP from Baseline to Week 12-7.3 ± 10.55-7.3 ± 10.75-9.5 ± 9.66
Week 1677.8 ± 10.3477.9 ± 11.6676.6 ± 8.42
Change in MSDBP from Baseline to Week 16-7.1 ± 10.78-7.5 ± 10.76-8.3 ± 8.62
SecondaryChange From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Time frame:
Baseline and Weeks 8, 12, and 16
Reported as:
Mean · mm Hg
Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
mm HgValsartanHCTZValsartan + HCTZ
Baseline166.2 ± 11.07164.5 ± 11.84164.5 ± 11.86
Week 8150.4 ± 20.29147.4 ± 18.69144.2 ± 19.93
Change in MSSBP from Baseline to Week 8-15.7 ± 20.43-17.1 ± 17.83-20.2 ± 19.12
Week 12148.6 ± 21.45145.1 ± 19.38142.0 ± 18.78
Change in MSSBP from Baseline to Week 12-17.5 ± 21.16-19.4 ± 19.19-22.5 ± 19.52
Week 16148.7 ± 20.06144.9 ± 19.59143.5 ± 18.69
Change in MSSBP from Baseline to Week 16-17.5 ± 19.62-19.7 ± 19.69-20.9 ± 18.49
SecondaryCumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg

Cumulative refers to achieving of blood pressure control before or at the corresponding visit.

Time frame:
Weeks 4, 8, 12 and 16
Reported as:
Number · Percentage of Participants
Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg
Percentage of ParticipantsValsartanHCTZValsartan + HCTZ
Week 42537.349.21
Week 840.6350.7963.49
Week 125061.1169.05
Week 1655.4766.6772.22
SecondaryCumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)

Cumulative refers to achieving blood pressure goal before or at the corresponding visit.

Time frame:
Weeks 4, 8, 12 and 16
Reported as:
Number · Percentage of Participants
Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)
Percentage of ParticipantsValsartanHCTZValsartan + HCTZ
Week 42538.8949.21
Week 840.6352.3863.49
Week 125062.7069.05
Week 1656.2568.2572.22
SecondaryTime in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])
Time frame:
During 16 weeks
Reported as:
Median · Weeks
Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])
WeeksValsartanHCTZValsartan + HCTZ
Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])12.0 (8.0 to 12.0)8.0 (7.0 to 12.0)4.0 (3.0 to 8.0)

Adverse events

Collected over 16 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Valsartan + HCTZ—3/128 (2.3%)16/128 (12.5%)
HCTZ—4/128 (3.1%)27/128 (21.1%)
Valsartan—3/128 (2.3%)23/128 (18%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventValsartan + HCTZHCTZValsartan
Atrial fibrillationCardiac disorders0/1281/1280/128
Gastric ulcer haemorrhageGastrointestinal disorders0/1280/1281/128
AppendicitisInfections and infestations0/1280/1281/128
PneumoniaInfections and infestations1/1280/1280/128
Clavicle fractureInjury, poisoning and procedural complications0/1280/1281/128
Spinal fractureInjury, poisoning and procedural complications0/1280/1281/128
Thoracic vertebral fractureInjury, poisoning and procedural complications0/1281/1280/128
Lung cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1280/1280/128
Cerebral haemorrhageNervous system disorders0/1280/1281/128
SyncopeNervous system disorders1/1281/1280/128
Most frequent other events
Most frequent other events
EventValsartan + HCTZHCTZValsartan
FatigueGeneral disorders5/12810/1285/128
DizzinessNervous system disorders5/1288/1289/128
HeadacheNervous system disorders6/1289/1283/128
Upper respiratory tract infectionInfections and infestations1/1284/1288/128

Baseline characteristics

Age Continuous
Age Continuous(years)ValsartanHCTZValsartan + HCTZTotal
Mean77.7 ± 4.2277.7 ± 4.8077.2 ± 3.9977.5 ± 4.34
Age, Customized
Age, Customized(participants)ValsartanHCTZValsartan + HCTZTotal
70-75 years414144126
76-80 years605665181
>80 years27311977
Sex: Female, Male
Sex: Female, Male(Participants)ValsartanHCTZValsartan + HCTZTotal
Female816271214
Male476657170
08

Study locations

20 sites
  • Investigative site
    Birmingham, Alabama, United States
  • Investigative site
    Phoenix, Arizona, United States
  • Investigative Site
    Escondido, California, United States
  • Investigative site
    Fresno, California, United States
  • Investigative site
    Huntington Park, California, United States
  • Investigative Sites
    Pismo Beach, California, United States
  • Investigative site
    Miami, Florida, United States
  • Investigative site
    Ormond Beach, Florida, United States
  • Investigative site
    Conyers, Georgia, United States
  • Investigative Site
    Lexington, Kentucky, United States
  • Investigative site
    Portland, Maine, United States
  • Investigative site
    Las Vegas, Nevada, United States
  • Investigative site
    Buffalo, New York, United States
  • Investigative site
    Shelby, North Carolina, United States
  • Investigative site
    Carlisle, Ohio, United States
  • Investigative site
    Oklahoma City, Oklahoma, United States
  • Investigative site
    Erie, Pennsylvania, United States
  • Investigative Site
    Greer, South Carolina, United States
  • Investigative Site
    Taylors, South Carolina, United States
  • Investigative site
    St George, Utah, United States
09

References and documents

Publications

  • Cushman WC, Duprez DA, Weintraub HS, Purkayastha D, Zappe D, Samuel R, Izzo JL Jr. Home and clinic blood pressure responses in elderly individuals with systolic hypertension. J Am Soc Hypertens. 2012 May-Jun;6(3):210-8. doi: 10.1016/j.jash.2012.03.001. PubMed 22520932 ↗
  • Weintraub HS, Duprez DA, Cushman WC, Zappe DH, Purkayastha D, Samuel R, Izzo JL Jr. Antihypertensive response to thiazide diuretic or angiotensin receptor blocker in elderly hypertensives is not influenced by pretreatment plasma renin activity. Cardiovasc Drugs Ther. 2012 Apr;26(2):145-55. doi: 10.1007/s10557-011-6365-x. PubMed 22311004 ↗
  • Izzo JL Jr, Weintraub HS, Duprez DA, Purkayastha D, Zappe D, Samuel R, Cushman WC. Treating systolic hypertension in the very elderly with valsartan-hydrochlorothiazide vs. either monotherapy: ValVET primary results. J Clin Hypertens (Greenwich). 2011 Oct;13(10):722-30. doi: 10.1111/j.1751-7176.2011.00498.x. Epub 2011 Jul 14. PubMed 21974759 ↗
  • Duprez DA, Weintraub HS, Cushman WC, Purkayastha D, Zappe D, Samuel R, Izzo JL Jr. Effect of valsartan, hydrochlorothiazide, and their combination on 24-h ambulatory blood pressure response in elderly patients with systolic hypertension: a ValVET substudy. Blood Press Monit. 2011 Aug;16(4):186-96. doi: 10.1097/MBP.0b013e32834944e9. PubMed 21747241 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00698646
Lead sponsor
Novartis Pharmaceuticals
First posted
Jun 17, 2008
Start date
Apr 2008
Primary completion
Jun 2009
Completion
Jun 2009
Results posted
Dec 15, 2010
Last update
Apr 19, 2011

Oversight

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

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