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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

October 28, 2009
October 29, 2009
August 9, 2012
November 2009
April 2012   (Final data collection date for primary outcome measure)
flow-mediated dilation [ Time Frame: 8 weeks of treatment ]
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Complete list of historical versions of study NCT01004237 on ClinicalTrials.gov Archive Site
insulin resistance [ Time Frame: 8 weeks of treatment ]
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Additive Effects of Pravastatin and Valsartan
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The investigators hypothesize that pravastatin combined with valsartan may have additive effects in hypertensive, hypercholesterolemic patients.
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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Hypertension
  • High Cholesterol
Drug: pravastatin, valsartan, pravastatin+valsartan
pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment
  • 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
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.
 
Completed
52
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April 2012
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hypertension and low-density lipoprotein cholesterol levels >100

Exclusion Criteria:

  • Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension
Sexes Eligible for Study: All
25 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01004237
GMC-200912
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Dr. Koh, Gachon University
Gachon University Gil Medical Center
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Gachon University Gil Medical Center
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP