Status:
COMPLETED
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
Lead Sponsor:
Novartis
Conditions:
HYPERTENSION
HYPERCHOLESTEROLEMIA
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 cholester...
Eligibility Criteria
Inclusion
- ESSENTIAL HYPERTENSION
- ELEVATED LDL-C CHOLESTEROL
- USING STABLE DOSE OF HMG CoA REDUCTASE INHIBITOR (STATIN) FOR 3+ MONTHS
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT00171093
Start Date
September 1 2004
Last Update
February 23 2017
Active Locations (1)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936