Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults - Full Text View

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00439738

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: High Blood Pressure Obesity

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline to Weeks 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
Change From Baseline in Postprandial Glucose [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Change From Baseline in Postprandial Insulin [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Change From Baseline in Postprandial Non-Esterified Fatty Acids [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Enrollment:	412
Study Start Date:	December 2006
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
valsartan/HCTZ: Experimental	Drug: Valsartan/HCTZ 160 mg film-coated valsartan tablets 320 mg film-coated valsartan tablets 12.5 mg HCTZ capsules 25 mg HCTZ capsules
HCTZ +Amlodipine: Active Comparator	Drug: HCTZ + Amlodipine 12.5 mg HCTZ capsules 25 mg HCTZ capsules 5 mg amlodipine capsules 10 mg amlodipine capsules

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
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

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

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CVAH631BUS06
Study First Received:	February 23, 2007
Results First Received:	November 5, 2008
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00439738 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Obesity, hypertension, valsartan/hydrochlorothiazide

Study placed in the following topic categories:

Obesity
Vasodilator Agents
Diuretics
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents

Antihypertensive Agents
Hydrochlorothiazide
Amlodipine
Calcium, Dietary
Valsartan
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Amlodipine
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009