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CompletedNCT01004237Updated Aug 9, 2012

Additive Effects of Pravastatin and Valsartan

A Phase 4 interventional study of pravastatin, valsartan, pravastatin+valsartan in Hypertension and High Cholesterol, sponsored by Gachon University Gil Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-08-09.

Sponsored by Gachon University Gil Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
25 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hypertension
  • High Cholesterol

Keywords

  • insulin resistance
  • hypertensive
  • hypercholesterolemic patients
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.

This study's enrollment of 52 is below the median of 100 across 992 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Gachon University Gil Medical Center is the lead sponsor of 88 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Hypertension and low-density lipoprotein cholesterol levels >100

Exclusion criteria

Exclusion Criteria:

  • Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
52 participants (actual)

Study arms

  • Active comparator
    pravastatin

    Drug: pravastatin, valsartan, pravastatin+valsartan

  • Active comparator
    valsartan

    Drug: pravastatin, valsartan, pravastatin+valsartan

  • Active comparator
    pravastatin combined with valsartan

    Drug: pravastatin, valsartan, pravastatin+valsartan

Interventions

  • Drugpravastatin, valsartan, pravastatin+valsartan

    pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment

06

What researchers measure

Primary outcomes

  1. flow-mediated dilation

    Time frame: 8 weeks of treatment

Secondary outcomes

  1. insulin resistance

    Time frame: 8 weeks of treatment

07

Study locations

1 site
  • Gil Medical Center
    Incheon, 405-760, Korea, Republic of
08

References and documents

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. PubMed 23863812 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01004237
Lead sponsor
Gachon University Gil Medical Center
First posted
Oct 29, 2009
Start date
Nov 2009
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Aug 9, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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