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

Completed · Phase 3

Conditions studied: HYPERTENSION, HYPERCHOLESTEROLEMIA

In brief

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..

Key facts

Study ID

NCT00171093

Run by

Novartis

People needed

369

Starts

2004-09-01

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• Other protocol-defined exclusion criteria may apply.

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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