A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential Hypertension and Hypercholesterolemia - Full Text View

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00254475

Purpose

The purpose of this study is to provide data on the dose response of simvastatin in lowering LDL-C when it is co-administered with valsartan in patients with both essential hypertension and hypercholesterolemia. The primary objective of the study will be to show that the combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the combination of valsartan 160mg/simvastatin 20mg in percentage change from baseline in LDL-C.

Condition	Intervention	Phase
Essential Hypertension Hypercholesterolemia	Drug: simvastatin Drug: valsartan	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Study to Evaluate the Efficacy of the Valsartan/Simvastatin Combinations 160/20mg up Titrated to 320/20mg Versus 160/40mg up Titrated to 320/40mg in Patients With Both 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:

Low density lipoproteins after 6 weeks

Secondary Outcome Measures:

Lipid profile at 6, 12 wks
BP < 140/90 mmHg in non diabetics, or < 130/80 mmHg in diabetics, and LDL-C < 2.6, 3.4 or 4.1 mmol/l based on risk group at 6, 12 wks
SBP < 140 mmHg in non diabetics, < 130 mmHg in diabetics, or 20 mmHg decrease in SBP from baseline and DBP < 90 mmHg in non diabetics, DBP < 80 mmHg in diabetics, or 10 mmHg decrease in DBP from baseline at 6, 12 wks
Systolic and diastolic bp at 6, 12 wks
Serious/adverse events, labs, physical exams, vitals up to 12 wks

Enrollment:	871
Study Start Date:	November 2005
Study Completion Date:	September 2006
Primary Completion Date:	September 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:

Elevated LDL-Cholesterol
Essential hypertension

Exclusion Criteria:

Severe Hypertension
Prior or known muscular or neuromuscular disease of any type
A history of cardiovascular disease
Hypertension or hypercholesterolemia due to secondary causes
Uncontrolled diabetes or insulin treatment
Evidence of hepatic or renal disease

Other protocol-defined exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254475

Locations

Germany

Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceutical

Novatis Pharmaceuticals

More Information

No publications provided by Novartis

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

Rump LC, Baranova E, Okopien B, Weisskopf M, Kandra A, Ferber P. Coadministration of valsartan 160 and 320 mg and simvastatin 20 and 40 mg in patients with hypertension and hypercholesterolemia: a multicenter, 12-week, double-blind, double-dummy, parallel-group superiority study. Clin Ther. 2008 Oct;30(10):1782-93.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00254475 History of Changes
Other Study ID Numbers:	CVAS489A2403
Study First Received:	November 7, 2005
Last Updated:	November 7, 2011
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Novartis:

Valsartan
simvastatin
hypertension
hypercholesterolemia
angiotensin II receptor blocker

Additional relevant MeSH terms:

Hypercholesterolemia
Hypertension
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Valsartan
Angiotensin Receptor Antagonists
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
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012