Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00277472

Purpose

This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.

Condition	Intervention	Phase
Hypertension	Drug: Valsartan/Hydrochlorothiazide Drug: HCTZ	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A 28-week, Multicenter Study to Evaluate the Effects of Valsartan/Hydrochlorothiazide (160/12.5 mg) in Comparison With Hydrochlorothiazide (25 mg) Monotherapy, for the Treatment of Patients With Hypertension, Uncontrolled by Hydrochlorothiazide (12.5 mg) Monotherapy

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 4 weeks
Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 2 weeks and 20 weeks

Secondary Outcome Measures:

Change from baseline in systolic blood pressure after 2 weeks and 4 weeks
Change from baseline in diastolic blood pressure after 2 weeks and 4 weeks
Change in systolic blood pressure at 20 weeks compared to 4 weeks
Change in diastolic blood pressure at 20 weeks compared to 4 weeks

Enrollment:	300
Study Start Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: valsartan HCTZ	Drug: Valsartan/Hydrochlorothiazide 160/12.5 mg taken once daily orally Other Name: Co-Diovan, Diovan HCT
Active Comparator: HCTZ	Drug: HCTZ 25 mg taken once daily orally Other Name: hydrochlorothiazice, water pill

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female 18 years of age and older
Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but < 180 mm Hg and mean seated diastolic blood pressure ≥ 95 mm Hg and <110 mm Hg

Exclusion Criteria:

- Patients with sever hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
Diabetes with fasting glucose > 126 mg/dl or on existing anti-diabetic medication
History of stroke, transient ischemic attack, or myocardial infarction within the last 6 months, or diagnosed with congestive heart failure.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277472

Locations

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

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis 862-778-8300 Pharmaceuticals

Novartis

More Information

Additional Information:

Click here for more information about this study. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Study Director, Novartis Pharma
ClinicalTrials.gov Identifier:	NCT00277472 History of Changes
Other Study ID Numbers:	CVAH631BUS04
Study First Received:	January 12, 2006
Last Updated:	June 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension
High blood pressure
diuretics
valsartan

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Valsartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012