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
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
1 other identifier
interventional
369
1 country
1
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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedFebruary 23, 2017
February 1, 2017
1.3 years
September 10, 2005
February 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in average ambulatory systolic blood pressure over 24 hours
Change in serum low density lipoprotein cholesterol (LDL-C )
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- ESSENTIAL HYPERTENSION
- ELEVATED LDL-C CHOLESTEROL
- USING STABLE DOSE OF HMG CoA REDUCTASE INHIBITOR (STATIN) FOR 3+ MONTHS
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 10, 2005
First Posted
September 15, 2005
Study Start
September 1, 2004
Primary Completion
January 1, 2006
Last Updated
February 23, 2017
Record last verified: 2017-02