A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential Hypertension and Hypercholesterolemia
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension; Hypercholesterolemia
Intervention: simvastatin (Drug); valsartan (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceutical, Study Director, Affiliation: Novatis Pharmaceuticals
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Low density lipoproteins after 6 weeks
Secondary outcome: Lipid profile at 6, 12 wksBP < 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Investigative Centers, Germany
Novartis Pharmaceuticals, Basel, Switzerland
Additional Information
Starting date: November 2005
Ending date: October 2006
Last updated: November 13, 2006
|
