NCT01120327

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Sep 2011

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 10, 2010

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

April 30, 2010

Last Update Submit

April 22, 2026

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Exercise capacity

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

    9 months

Secondary Outcomes (2)

  • Sublingual Nitrate

    1month and 3 months

  • Biomarkers

    9 months

Study Arms (2)

Amlodipine

EXPERIMENTAL

Amlodipine

Drug: Amlodipine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PlaceboDRUG

Placebo

Placebo
AmlodipineDRUG

Amlodipine

Amlodipine

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hyo-Soo Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

April 30, 2010

First Posted

May 10, 2010

Study Start

September 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations

KR(1)