Back to resultsAdditive Effects of Pravastatin and Valsartan
Primary Purpose
Hypertension, High Cholesterol
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pravastatin, valsartan, pravastatin+valsartan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring insulin resistance, hypertensive, hypercholesterolemic patients
Eligibility 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
Sites / Locations
- Gil Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
pravastatin
valsartan
pravastatin combined with valsartan
Arm Description
Outcomes
Primary Outcome Measures
flow-mediated dilation
Secondary Outcome Measures
insulin resistance
Full Information
NCT ID
NCT01004237
First Posted
October 28, 2009
Last Updated
August 8, 2012
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01004237
Brief Title
Additive Effects of Pravastatin and Valsartan
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
5. Study Description
Brief Summary
The investigators hypothesize that pravastatin combined with valsartan may have additive effects in hypertensive, hypercholesterolemic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, High Cholesterol
Keywords
insulin resistance, hypertensive, hypercholesterolemic patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pravastatin
Arm Type
Active Comparator
Arm Title
valsartan
Arm Type
Active Comparator
Arm Title
pravastatin combined with valsartan
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
pravastatin, valsartan, pravastatin+valsartan
Intervention Description
pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment
Primary Outcome Measure Information:
Title
flow-mediated dilation
Time Frame
8 weeks of treatment
Secondary Outcome Measure Information:
Title
insulin resistance
Time Frame
8 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Gil Medical Center
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23863812
Citation
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.
Results Reference
derived
Learn more about this trial
Additive Effects of Pravastatin and Valsartan
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