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Additive Effects of Pravastatin and Valsartan

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ClinicalTrials.gov Identifier: NCT01004237
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : August 9, 2012
Sponsor:
Information provided by:
Gachon University Gil Medical Center

Tracking Information
First Submitted Date  ICMJE October 28, 2009
First Posted Date  ICMJE October 29, 2009
Last Update Posted Date August 9, 2012
Study Start Date  ICMJE November 2009
Actual 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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2011)
insulin resistance [ Time Frame: 8 weeks of treatment ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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 Arms  ICMJE
  • 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 * Koh KK, Lim S, Choi H, Lee Y, Han SH, Lee K, Oh PC, Sakuma I, Shin EK, Quon MJ. Combination pravastatin and valsartan treatment has additive beneficial effects to simultaneously improve both metabolic and cardiovascular phenotypes beyond that of monotherapy with either drug in patients with primary hypercholesterolemia. Diabetes. 2013 Oct;62(10):3547-52. doi: 10.2337/db13-0566. Epub 2013 Jul 17.

*   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
Actual Enrollment  ICMJE
 (submitted: August 8, 2012)
52
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2012
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004237
Other Study ID Numbers  ICMJE GMC-200912
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Koh, Gachon University
Study Sponsor  ICMJE Gachon University Gil Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account 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