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Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00439738
First received: February 23, 2007
Last updated: April 19, 2017
Last verified: April 2017
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Purpose
The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients.
| Condition | Intervention | Phase |
|---|---|---|
| Hypertension | Drug: HCTZ + Amlodipine Drug: Valsartan/HCTZ | Phase 4 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline to Week 8 ]
Secondary Outcome Measures:
- 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
| Enrollment: | 412 |
| Study Start Date: | December 2006 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: valsartan/HCTZ |
Drug: Valsartan/HCTZ
|
| Active Comparator: HCTZ +Amlodipine |
Drug: HCTZ + Amlodipine
|
Eligibility| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439738
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439738
Locations
| 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 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
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 |
| Study First Received: | February 23, 2007 |
| Results First Received: | November 5, 2008 |
| Last Updated: | April 19, 2017 |
Keywords provided by Novartis:
|
Obesity, hypertension, valsartan/hydrochlorothiazide |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Valsartan Hydrochlorothiazide Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors |
ClinicalTrials.gov processed this record on August 18, 2017