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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
  Purpose

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


Condition Intervention Phase
Hypertension
High Cholesterol
 Drug: pravastatin, valsartan, pravastatin+valsartan
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • flow-mediated dilation [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin resistance [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: November 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004237

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

No publications provided

Responsible Party: Dr. Koh, Gachon University
ClinicalTrials.gov Identifier: NCT01004237     History of Changes
Other Study ID Numbers: GMC-200912
Study First Received: October 28, 2009
Last Updated: August 8, 2012
Health Authority: South Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 22, 2013