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OpenTrials
Completed

NCT Number: NCT01120327

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo

Drug

Placebo

Amlodipine

Drug

Amlodipine

Primary outcomes

  1. Exercise capacity

    Time frame: 9 months

    Difference of the peak oxygen uptake change (VO2 max, mL/kg/min)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 10, 2010
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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