Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults
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ClinicalTrials.gov Identifier: NCT00439738 |
Recruitment Status :
Completed
First Posted : February 26, 2007
Results First Posted : February 10, 2009
Last Update Posted : May 16, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: HCTZ + Amlodipine Drug: Valsartan/HCTZ | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 412 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A 16-week Double-blind, Randomized, Multicenter, Force-titration Study to Evaluate the Antihypertensive Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Therapy Compared to HCTZ Based Therapy in Obese, Hypertensive Patients |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | November 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: valsartan/HCTZ |
Drug: Valsartan/HCTZ
|
Active Comparator: HCTZ +Amlodipine |
Drug: HCTZ + Amlodipine
|
- Change in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline to Week 8 ]
- Change in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline to Weeks 4, 8, 12 and 16 ]
- Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg) [ Time Frame: Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16) ]Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 140/90 mm Hg
- Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg) [ Time Frame: Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16) ]Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 130/80 mm Hg
- Change From Baseline in Postprandial Glucose [ Time Frame: Week 16 ]After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
- Change From Baseline in Postprandial Insulin [ Time Frame: Week 16 ]After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
- Change From Baseline in Postprandial Non-esterified Fatty Acids [ Time Frame: Week 16 ]After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 40 years of age or older
- Moderate or severe high blood pressure defined as systolic blood pressure (the top number) greater than or equal to 150 mmHg and diastolic blood pressure (the bottom number) less then 110 mmHg
- Central (abdominal) obesity
Exclusion Criteria:
- Systolic blood pressure (the top number) greater than or equal to 180 mmHg and diastolic blood pressure (the bottom number) greater than or equal to 110 mmHg
- Currently taking more then 3 medications to treat high blood pressure
- Inability to stop all current blood pressure medications if any up to 4 weeks
- History of Type 1 or Type 2 diabetes
- History of stroke, mini-stroke (transient ischemic attack) or heart attack within the last 6 months
- History of or current diagnosis of congestive heart failure
- History of cancer within the past 5 years with the exception of localized basal cell carcinoma or squamous cell carcinoma
- Women who are pregnant or nursing
- Alcohol or drug abuse within the last 2 years
Other protocol-defined inclusion/exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439738
United States, Alabama | |
Terence T. Hart, MD | |
Muscle Shoals, Alabama, United States, 35662 | |
United States, California | |
Westlake Medical Research | |
Westlake Village, California, United States, 91361 | |
United States, Oklahoma | |
Oklahoma Cardiovascular & Hypertension | |
Oklahoma City, Oklahoma, United States, 73132 | |
United States, Texas | |
Northeast Tarrant Internal Medicine Assoc | |
Euless, Texas, United States, 76040 | |
United States, Washington | |
Frandsen Family Medicine | |
Port Orchard, Washington, United States, 98366 |
Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | External Affairs, Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00439738 History of Changes |
Other Study ID Numbers: |
CVAH631BUS06 |
First Posted: | February 26, 2007 Key Record Dates |
Results First Posted: | February 10, 2009 |
Last Update Posted: | May 16, 2017 |
Last Verified: | April 2017 |
Obesity, hypertension, valsartan/hydrochlorothiazide |
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Valsartan Hydrochlorothiazide Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Diuretics Natriuretic Agents Sodium Chloride Symporter Inhibitors |