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

Sponsor:	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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

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:

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
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

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

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zappe DH, Palmer BF, Calhoun DA, Purkayastha D, Samuel R, Jamerson KA. Effectiveness of initiating treatment with valsartan/hydrochlorothiazide in patients with stage-1 or stage-2 hypertension. J Hum Hypertens. 2010 Jul;24(7):483-91. Epub 2009 Dec 10.

ClinicalTrials.gov Identifier:	NCT00280540 History of Changes
Other Study ID Numbers:	CVAH631BUS05
Study First Received:	January 19, 2006
Last Updated:	November 5, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension
High blood pressure
Blood pressure control
Blood pressure reduction
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 May 21, 2012