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NCT01004237 Clinical Trial

Additive Effects of Pravastatin and Valsartan

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01004237
Other study ID # GMC-200912
Secondary ID
Status Completed
Phase Phase 4
First received October 28, 2009
Last updated August 8, 2012
Start date November 2009
Est. completion date April 2012

Study information
Verified date October 2010
Source Gachon University Gil Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The investigators hypothesize that pravastatin combined with valsartan may have additive effects in hypertensive, hypercholesterolemic patients.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 75 Years
Eligibility Inclusion Criteria:

- Hypertension and low-density lipoprotein cholesterol levels >100

Exclusion Criteria:

- Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• pravastatin, valsartan, pravastatin+valsartan
pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment

Locations
Country Name City State
Korea, Republic of Gil Medical Center Incheon

Sponsors (1)
Lead Sponsor Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary flow-mediated dilation 8 weeks of treatment No
Secondary insulin resistance 8 weeks of treatment No
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