A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Seoul National University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01120327
First received: April 30, 2010
Last updated: May 7, 2010
Last verified: May 2010
  Purpose
  1. OBJECTIVES

    Primary objective to evaluate the difference of the peak oxygen uptake change (VO2 max, mL/kg/min) in amlodipine group against no CCB group at 9 months

    Secondary objectives To evaluate the change of sublingual nitrate use per day against no CCB group at 1 and 3 months To evaluate the change of biomarkers against no CCB group at 9 months

  2. SUBJECTS AND CENTERS 212, stable angina patients with angiographically confirmed significant residual stenosis 10, 3rd-grade, teaching hospitals in Korea

Condition Intervention Phase
Coronary Artery Disease
Drug: Placebo
Drug: Amlodipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Exercise capacity [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Difference of the peak oxygen uptake change (VO2 max, mL/kg/min)


Secondary Outcome Measures:
  • Sublingual Nitrate [ Time Frame: 1month and 3 months ] [ Designated as safety issue: Yes ]
    To evaluate the change of sublingual nitrate use per day against no CCB group at 1 and 3 months

  • Biomarkers [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    To evaluate the change of biomarkers against no CCB group at 9 months


Estimated Enrollment: 212
Study Start Date: July 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amlodipine
Amlodipine
Drug: Amlodipine
Amlodipine
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable angina patient with angiographically confirmed significant residual stenosis
  • Stenosis more than 50% in 2 major coronary arteries at least or Stenosis more than 75% in 1 major coronary artery

Exclusion Criteria:

  • No other pulmonary/psychiatry/musculoskeletal disorder limiting CPET
  • Contraindicated to the CPET (e.g. unstable angina, aortic stenosis, uncontrolled hypertension, uncontrolled asthma, hypoxemia at rest, epilepsy, locomotor disorder, severe hypertension and febrile illness)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120327

Contacts
Contact: Hae-Young Lee, MD, PhD 82-10-4528-6160 hylee612@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Hae-Young Lee, MD, PhD    82-10-4528-6160    hylee612@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hyo-Soo Kim, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Hyo-Soo, Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01120327     History of Changes
Other Study ID Numbers: Amlodipine study
Study First Received: April 30, 2010
Last Updated: May 7, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 20, 2014