MedDataX Logo

Additive Effects of Pravastatin and Valsartan

NCT ID: NCT01004237

Last Updated: 2012-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension High Cholesterol

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

insulin resistance hypertensive hypercholesterolemic patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

pravastatin

Group Type ACTIVE_COMPARATOR

pravastatin, valsartan, pravastatin+valsartan

Intervention Type DRUG

pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment

valsartan

Group Type ACTIVE_COMPARATOR

pravastatin, valsartan, pravastatin+valsartan

Intervention Type DRUG

pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment

pravastatin combined with valsartan

Group Type ACTIVE_COMPARATOR

pravastatin, valsartan, pravastatin+valsartan

Intervention Type DRUG

pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pravastatin, valsartan, pravastatin+valsartan

pravastatin 40 mg, valsartan 160 mg 8 weeks of treatment

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Hypertension and low-density lipoprotein cholesterol levels \>100

Exclusion Criteria

* Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gachon University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gil Medical Center

Incheon, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23863812 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GMC-200912

Identifier Type: -

Identifier Source: org_study_id