ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01120327
Recruitment Status : Unknown
Verified May 2010 by Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 10, 2010
Last Update Posted : May 10, 2010
Sponsor:
Information provided by:
Seoul National University Hospital

Brief Summary:
  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 or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Placebo Drug: Amlodipine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients
Study Start Date : July 2010
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Experimental: Amlodipine
Amlodipine
Drug: Amlodipine
Amlodipine

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Exercise capacity [ Time Frame: 9 months ]
    Difference of the peak oxygen uptake change (VO2 max, mL/kg/min)


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

  2. Biomarkers [ Time Frame: 9 months ]
    To evaluate the change of biomarkers against no CCB group at 9 months



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hyo-Soo, Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01120327     History of Changes
Other Study ID Numbers: Amlodipine study
First Posted: May 10, 2010    Key Record Dates
Last Update Posted: May 10, 2010
Last Verified: May 2010

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