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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
History of Changes

April 30, 2010
May 7, 2010
July 2010
July 2011   (final data collection date for primary outcome measure)
Exercise capacity [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Difference of the peak oxygen uptake change (VO2 max, mL/kg/min)
Same as current
Complete list of historical versions of study NCT01120327 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients
A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients

  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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: Placebo
    Placebo
  • Drug: Amlodipine
    Amlodipine
  • Experimental: Amlodipine
    Amlodipine
    Intervention: Drug: Amlodipine
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
212
December 2011
July 2011   (final data collection date for primary outcome measure)

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)
Both
20 Years to 80 Years
No
Contact: Hae-Young Lee, MD, PhD 82-10-4528-6160 hylee612@snu.ac.kr
Korea, Republic of
 
NCT01120327
Amlodipine study
Yes
Hyo-Soo, Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Hyo-Soo Kim, MD, PhD Seoul National University Hospital
Seoul National University Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP