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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.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00254475
First received: November 7, 2005
Last updated: November 7, 2011
Last verified: October 2006
History of Changes

November 7, 2005
November 7, 2011
November 2005
September 2006   (final data collection date for primary outcome measure)
Low density lipoproteins after 6 weeks
Not Provided
Complete list of historical versions of study NCT00254475 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential Hypertension and Hypercholesterolemia
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Essential Hypertension
  • Hypercholesterolemia
  • Drug: simvastatin
  • Drug: valsartan
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
871
September 2006
September 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
 
NCT00254475
CVAS489A2403
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceutical Novatis Pharmaceuticals
Novartis
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP