Back to resultsA 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and Hypercholesterolemia
Primary Purpose
HYPERTENSION, HYPERCHOLESTEROLEMIA
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
valsartan + simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for HYPERTENSION focused on measuring HYPERTENSION, HYPERCHOLESTEROLEMIA, BLOOD PRESSURE, CHOLESTEROL, VALSARTAN, SIMVASTATIN
Eligibility Criteria
Inclusion Criteria: ESSENTIAL HYPERTENSION ELEVATED LDL-C CHOLESTEROL USING STABLE DOSE OF HMG CoA REDUCTASE INHIBITOR (STATIN) FOR 3+ MONTHS Exclusion Criteria: SEVERE HYPERTENSION EVIDENCE OF HISTORY OR CURRENT HEART DISEASE HISTORY OF STROKE OR MYOCARDIAL INFARCTION DISLIPIDEMIA OR HYPERTENSION DUE TO SECONDARY CAUSES UNCONTROLLED DIABETES OR INSULIN Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
Primary Outcome Measures
Change in average ambulatory systolic blood pressure over 24 hours
Change in serum low density lipoprotein cholesterol (LDL-C )
Secondary Outcome Measures
Adverse events and serious adverse events at each study visit for 42 days
Change in average ambulatory systolic blood pressure over 24 hours between two different treatment therapies
Change in 24 hour ambulatory blood pressure in the daytime compared to nighttime
Change in 24 hour ambulatory blood pressure 21-24 hours after last dose of study medication
Change in total cholesterol, triglycerides, and high densitiy lipoprotein cholesterol (HDL-C) from baseline after 42 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171093
Brief Title
A 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and Hypercholesterolemia
Official Title
A 10-12 Week Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of the Combination of Valsartan (320 mg) and Simvastatin (80 mg) Compared to Valsartan (320 mg) and Simvastatin (80 mg) Monotherapies in Essential Hypertension and Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and 80 mg simvastatin together compared to using either one alone in lowering blood pressure and LDL cholesterol. After discontinuing current drug therapies for hypertension and hypercholesterolemia, patients will be given 320mg valsartan+80mg simvastatin, 320mg valsartan+placebo, or 80mg simvastatin+placebo..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HYPERTENSION, HYPERCHOLESTEROLEMIA
Keywords
HYPERTENSION, HYPERCHOLESTEROLEMIA, BLOOD PRESSURE, CHOLESTEROL, VALSARTAN, SIMVASTATIN
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
369 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valsartan + simvastatin
Primary Outcome Measure Information:
Title
Change in average ambulatory systolic blood pressure over 24 hours
Title
Change in serum low density lipoprotein cholesterol (LDL-C )
Secondary Outcome Measure Information:
Title
Adverse events and serious adverse events at each study visit for 42 days
Title
Change in average ambulatory systolic blood pressure over 24 hours between two different treatment therapies
Title
Change in 24 hour ambulatory blood pressure in the daytime compared to nighttime
Title
Change in 24 hour ambulatory blood pressure 21-24 hours after last dose of study medication
Title
Change in total cholesterol, triglycerides, and high densitiy lipoprotein cholesterol (HDL-C) from baseline after 42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
Inclusion Criteria:
ESSENTIAL HYPERTENSION
ELEVATED LDL-C CHOLESTEROL
USING STABLE DOSE OF HMG CoA REDUCTASE INHIBITOR (STATIN) FOR 3+ MONTHS
Exclusion Criteria:
SEVERE HYPERTENSION
EVIDENCE OF HISTORY OR CURRENT HEART DISEASE
HISTORY OF STROKE OR MYOCARDIAL INFARCTION
DISLIPIDEMIA OR HYPERTENSION DUE TO SECONDARY CAUSES
UNCONTROLLED DIABETES OR INSULIN
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
E. Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and Hypercholesterolemia
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