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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: November 7, 2005
Last updated: August 18, 2014
Last verified: August 2014
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
Drug: simvastatin
Drug: valsartan
Phase 3

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:

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both

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
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Please refer to this study by its identifier: NCT00254475

Investigative Centers, Germany
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Study Director: Novartis Pharmaceutical Novatis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT00254475     History of Changes
Other Study ID Numbers: CVAS489A2403 
Study First Received: November 7, 2005
Last Updated: August 18, 2014
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Novartis:
angiotensin II receptor blocker

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on October 21, 2016