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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00254475
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : August 19, 2014
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Essential Hypertension Hypercholesterolemia Drug: simvastatin Drug: valsartan Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 871 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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
Study Start Date : November 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Low density lipoproteins after 6 weeks

Secondary Outcome Measures :
  1. Lipid profile at 6, 12 wks
  2. 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
  3. 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
  4. Systolic and diastolic bp at 6, 12 wks
  5. Serious/adverse events, labs, physical exams, vitals up to 12 wks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00254475

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT00254475     History of Changes
Other Study ID Numbers: CVAS489A2403
First Posted: November 16, 2005    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014

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