A 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and Hypercholesterolemia - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171093

Purpose

This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and 80 mg simvastatin together compared to using either one alone in lowering blood pressure and LDL cholesterol. After discontinuing current drug therapies for hypertension and hypercholesterolemia, patients will be given 320mg valsartan+80mg simvastatin, 320mg valsartan+placebo, or 80mg simvastatin+placebo..

Condition	Intervention	Phase
Hypertension Hypercholesterolemia	Drug: valsartan + simvastatin	Phase III

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 10-12 Week Multicenter, Double-Blind Study to Evaluate the Efficacy and Safety of the Combination of Valsartan (320 mg) and Simvastatin (80 mg) Compared to Valsartan (320 mg) and Simvastatin (80 mg) Monotherapies in Essential Hypertension and Hypercholesterolemia

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol High Blood Pressure

Drug Information available for: Simvastatin Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change in average ambulatory systolic blood pressure over 24 hours
Change in serum low density lipoprotein cholesterol (LDL-C )

Secondary Outcome Measures:

Adverse events and serious adverse events at each study visit for 42 days
Change in average ambulatory systolic blood pressure over 24 hours between two different treatment therapies
Change in 24 hour ambulatory blood pressure in the daytime compared to nighttime
Change in 24 hour ambulatory blood pressure 21-24 hours after last dose of study medication
Change in total cholesterol, triglycerides, and high densitiy lipoprotein cholesterol (HDL-C) from baseline after 42 days

Estimated Enrollment:	369
Study Start Date:	September 2004
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

ESSENTIAL HYPERTENSION
ELEVATED LDL-C CHOLESTEROL
USING STABLE DOSE OF HMG CoA REDUCTASE INHIBITOR (STATIN) FOR 3+ MONTHS

Exclusion Criteria:

SEVERE HYPERTENSION
EVIDENCE OF HISTORY OR CURRENT HEART DISEASE
HISTORY OF STROKE OR MYOCARDIAL INFARCTION
DISLIPIDEMIA OR HYPERTENSION DUE TO SECONDARY CAUSES
UNCONTROLLED DIABETES OR INSULIN

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171093

Locations

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

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00171093 History of Changes
Other Study ID Numbers:	CVAS489A2316
Study First Received:	September 10, 2005
Last Updated:	September 19, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

HYPERTENSION
HYPERCHOLESTEROLEMIA
BLOOD PRESSURE

CHOLESTEROL
VALSARTAN
SIMVASTATIN

Additional relevant MeSH terms:

Hypercholesterolemia
Hypertension
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Valsartan
Hypolipidemic Agents
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012