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

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00439738

First received: February 23, 2007

Last updated: February 9, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2007

Last Updated Date

February 9, 2009

Start Date ^ICMJE

December 2006

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in MSSBP from baseline to Week 8

Change History

Complete list of historical versions of study NCT00439738 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Change in mean sitting diastolic blood pressure (MSDBP) from baseline to Weeks 4, 8, 12 and 16
Proportion of patients achieving blood pressure (BP) control at Weeks 4, 8, 12 and 16
Change from baseline in postprandial glucose, insulin and non-esterified fatty acids 2 hours after an oral glucose tolerance test at Week 16
Evaluate safety and tolerability baseline to Week 16

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

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

Study Arm (s)

Experimental: valsartan/HCTZ
Intervention: Drug: Valsartan/HCTZ
Active Comparator: HCTZ +Amlodipine
Intervention: Drug: HCTZ + Amlodipine

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

412

Completion Date

Not Provided

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00439738

Other Study ID Numbers ^ICMJE

CVAH631BUS06

Has Data Monitoring Committee

Not Provided

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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