8-Week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension

This study has been completed.

First Received: May 16, 2006 Last Updated: October 24, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00327587

Purpose

The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.

Condition	Intervention	Phase
Hypertension	Drug: Valsartan + amlodipine Drug: Valsartan + HCTZ Drug: Amlodipine + HCTZ Drug: Valsartan + amlodipine + HCTZ	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An 8-Week, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Valsartan/HCTZ/Amlodipine Compared to Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in Patients With Moderate to Severe Hypertension.

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline diastolic blood pressure after 8 weeks
Change from baseline systolic blood pressure after 8 weeks

Secondary Outcome Measures:

Blood pressure less than 140/90 mmHg after 8 weeks
Systolic blood pressure less than 140 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks
Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease after 8 weeks or systolic blood pressure less than 140 mmHg or at least a 15 mmHg decrease after 8 weeks
Ambulatory blood pressure and standing systolic and diastolic blood pressure measurements
Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 8 weeks

Estimated Enrollment:	2252
Study Start Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and < 120 mmHg, MSSBP ≥ 145 mmHg and < 200 mmHg).

Exclusion Criteria:

Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit 1.
Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and < 110 mmHg, and/or MSSBP ≥ 140 mmHg and < 180 mmHg at Visit 1.
Patients on four or more antihypertensive drugs at Visit 1.
Arm circumference > 42 cm for patients participating in ABPM.

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327587

Locations

United States, New Jersey
Novartis Pharmaceuticals Corporation
E. Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CVEA489A2302
Study First Received:	May 16, 2006
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00327587 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

hypertension
valsartan
amlodipine
HCTZ

Study placed in the following topic categories:

Calcium, Dietary
Vasodilator Agents
Sodium Chloride Symporter Inhibitors
Diuretics
Vascular Diseases
Calcium Channel Blockers

Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Valsartan
Amlodipine
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 July 02, 2009