Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

This study has been completed.

First Received: January 19, 2006 Last Updated: March 20, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00280540

Purpose

This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).

Condition	Intervention	Phase
Hypertension	Drug: Valsartan/Hydrochlorothiazide	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Valsartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 6-Week Treatment Regimen Study to Evaluate the Efficacy of Initial High Dose Valsartan Monotherapy (160 mg) or Combo Therapy (Valsartan + Hydrochlorothiazide, 160/12.5 mg) to Conventional Low-Dose Valsartan Monotherapy (80 mg) in Managing Patients With Hypertension

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline systolic blood pressure after 4 weeks
Change from baseline systolic blood pressure after 2 and 6 weeks

Secondary Outcome Measures:

Time in weeks to achieve blood pressure less than 140/90 mmHg over 6 week period
Blood pressure less than 140/90 mmHg after 6 weeks
Change from baseline diastolic blood pressure after 6 weeks
Change from baseline in blood and urine markers after 6 weeks

Estimated Enrollment:	648
Study Start Date:	December 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Male or female age 18 or older
Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but < 180 mm Hg and mean seated diastolic blood pressure ≥ 90 mm Hg and <110 mm Hg)

Exclusion Criteria:

Patients with severe hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma etc.)
History of myocardial infarction, stroke [e.g. cerebrovascular accident (CVA), thrombotic stroke, transient ischemic attack (TIA)], or onset of heart failure within the last 6 months.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280540

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

Novartis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CVAH631BUS05
Study First Received:	January 19, 2006
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00280540 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension
High blood pressure
Blood pressure control
Blood pressure reduction
Valsartan

Study placed in the following topic categories:

Sodium Chloride Symporter Inhibitors
Diuretics
Vascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Hydrochlorothiazide
Valsartan
Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

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

ClinicalTrials.gov processed this record on May 07, 2009