Additive Effects of Pravastatin and Valsartan

This study has been completed.

Sponsor:

Information provided by:

Gachon University Gil Medical Center

ClinicalTrials.gov Identifier:

NCT01004237

First received: October 28, 2009

Last updated: August 8, 2012

Last verified: October 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	October 28, 2009
Last Updated Date	August 8, 2012
Start Date ^ICMJE	November 2009
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 9, 2011)	flow-mediated dilation [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01004237 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 9, 2011)	insulin resistance [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Additive Effects of Pravastatin and Valsartan
Official Title ^ICMJE	Not Provided
Brief Summary	The investigators hypothesize that pravastatin combined with valsartan may have additive effects in hypertensive, hypercholesterolemic patients.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Hypertension High Cholesterol
Intervention ^ICMJE	Drug: pravastatin, valsartan, pravastatin+valsartan pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment
Study Arm (s)	Active Comparator: pravastatin Intervention: Drug: pravastatin, valsartan, pravastatin+valsartan Active Comparator: valsartan Intervention: Drug: pravastatin, valsartan, pravastatin+valsartan Active Comparator: pravastatin combined with valsartan Intervention: Drug: pravastatin, valsartan, pravastatin+valsartan
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	52
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Hypertension and low-density lipoprotein cholesterol levels >100 Exclusion Criteria: Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension
Gender	Both
Ages	25 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01004237
Other Study ID Numbers ^ICMJE	GMC-200912
Has Data Monitoring Committee	Not Provided
Responsible Party	Dr. Koh, Gachon University
Study Sponsor ^ICMJE	Gachon University Gil Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Gachon University Gil Medical Center
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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