Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00439738

First Posted: February 26, 2007

Last Update Posted: May 16, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Novartis

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:

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Valsartan

U.S. FDA Resources

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 160 mg film-coated valsartan tablets 320 mg film-coated valsartan tablets 12.5 mg HCTZ capsules 25 mg HCTZ capsules
Active Comparator: HCTZ +Amlodipine	Drug: HCTZ + Amlodipine 12.5 mg HCTZ capsules 25 mg HCTZ capsules 5 mg amlodipine capsules 10 mg amlodipine capsules

Eligibility

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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

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:

Results for CVAH631BUS06 from the Novartis Clinical Trials website This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Deedwania PC, Zappe DH, Egan BM, Purkayastha D, Samuel R, Sowers JR. Does response of RAS blockade on serum K+ levels influence its glycemic-mitigating response when combined with hydrochlorothiazide? J Clin Hypertens (Greenwich). 2012 Jul;14(7):415-21. doi: 10.1111/j.1751-7176.2012.00635.x. Epub 2012 Apr 26.

Ofili EO, Zappe DH, Purkayastha D, Samuel R, Sowers JR. Antihypertensive and metabolic effects of Angiotensin receptor blocker/diuretic combination therapy in obese, hypertensive African American and white patients. Am J Ther. 2013 Jan;20(1):2-12. doi: 10.1097/MJT.0b013e318230ae66.

Sowers JR, Raij L, Jialal I, Egan BM, Ofili EO, Samuel R, Zappe DH, Purkayastha D, Deedwania PC. Angiotensin receptor blocker/diuretic combination preserves insulin responses in obese hypertensives. J Hypertens. 2010 Aug;28(8):1761-9. doi: 10.1097/HJH.0b013e32833af380.


Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00439738 History of Changes
Other Study ID Numbers:	CVAH631BUS06
First Submitted:	February 23, 2007
First Posted:	February 26, 2007
Results First Submitted:	November 5, 2008
Results First Posted:	February 10, 2009
Last Update Posted:	May 16, 2017
Last Verified:	April 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

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