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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:

Study Description
Brief Summary:
The investigators hypothesize that pravastatin combined with valsartan may have additive effects in hypertensive, hypercholesterolemic patients.

Condition or disease Intervention/treatment Phase
Hypertension High Cholesterol Drug: pravastatin, valsartan, pravastatin+valsartan Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : November 2009
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: pravastatin Drug: pravastatin, valsartan, pravastatin+valsartan
pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment
Active Comparator: valsartan Drug: pravastatin, valsartan, pravastatin+valsartan
pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment
Active Comparator: pravastatin combined with valsartan Drug: pravastatin, valsartan, pravastatin+valsartan
pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment


Outcome Measures

Primary Outcome Measures :
  1. flow-mediated dilation [ Time Frame: 8 weeks of treatment ]

Secondary Outcome Measures :
  1. insulin resistance [ Time Frame: 8 weeks of treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertension and low-density lipoprotein cholesterol levels >100

Exclusion Criteria:

  • Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004237


Locations
Korea, Republic of
Gil Medical Center
Incheon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Koh, Gachon University
ClinicalTrials.gov Identifier: NCT01004237     History of Changes
Other Study ID Numbers: GMC-200912
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: August 9, 2012
Last Verified: October 2010

Keywords provided by Gachon University Gil Medical Center:
insulin resistance
hypertensive
hypercholesterolemic patients

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Valsartan
Pravastatin
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors