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

Primary Purpose

Essential Hypertension, Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
simvastatin
valsartan
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Valsartan, simvastatin, hypertension, hypercholesterolemia, angiotensin II receptor blocker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Novartis Pharmaceuticals

Outcomes

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

Full Information

First Posted
November 7, 2005
Last Updated
August 18, 2014
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00254475
Brief Title
A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential Hypertension and Hypercholesterolemia
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 Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension, Hypercholesterolemia
Keywords
Valsartan, simvastatin, hypertension, hypercholesterolemia, angiotensin II receptor blocker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
871 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
simvastatin
Intervention Type
Drug
Intervention Name(s)
valsartan
Primary Outcome Measure Information:
Title
Low density lipoproteins after 6 weeks
Secondary Outcome Measure Information:
Title
Lipid profile at 6, 12 wks
Title
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
Title
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
Title
Systolic and diastolic bp at 6, 12 wks
Title
Serious/adverse events, labs, physical exams, vitals up to 12 wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceutical
Organizational Affiliation
Novatis Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Investigative Centers
Country
Germany
Facility Name
Novartis Pharmaceuticals
City
Basel
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19014834
Citation
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. doi: 10.1016/j.clinthera.2008.10.004.
Results Reference
derived

Learn more about this trial

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

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