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Safety and Effects of Ramipril Combined With Candesartan

This study has been completed.
Sponsor:
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT00356395
First received: July 25, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

we hypothesized that combination therapy has additive beneficial effects to improve endothelial dysfunction and adipocytokine profiles in patients with hypertension.


Condition Intervention Phase
Hypertension
 Drug: ramipril, candesartan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Cardiovascular and Metabolic Effects of Combination Therapy With Ramipril and Candesartan In Hypertensive Patients

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • comparison of endothelium-dependent dilation among the 3 treatment schemes

Estimated Enrollment: 40
Study Start Date: August 2003
Estimated Study Completion Date: March 2006
Detailed Description:

Forty patients will be given ramipril 10 mg and placebo, ramipril 10 mg and candesartan 16 mg, or candesartan 16 mg and placebo daily in a randomized, double-blind, placebo-controlled cross-over trial with three treatment arms and two washout periods (each 2 months).

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with mild to moderate hypertension

Exclusion Criteria:

  • We will exclude patients with severe hypertension, unstable angina, acute myocardial infarction, or renal insufficiency.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356395

Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Principal Investigator: Kwang K Koh, MD Cardiology, Gil Heart Center, Gachon Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00356395     History of Changes
Other Study ID Numbers: 2003-008
Study First Received: July 25, 2006
Last Updated: July 25, 2006
Health Authority: Korea: Food and Drug Administration

Keywords provided by Gachon University Gil Medical Center:
endothelial function, insulin resistance, adipocytokines

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Ramipril
Candesartan
Candesartan cilexetil
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 22, 2013