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CompletedNCT01120327Updated Apr 27, 2026

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

A Phase 4 interventional study of Placebo and Amlodipine in Coronary Artery Disease, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
211
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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
02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 211 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
211 participants (actual)

Study arms

  • Experimental
    Amlodipine

    Amlodipine

    Drug: Amlodipine

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

Interventions

  • DrugPlacebo

    Placebo

  • DrugAmlodipine

    Amlodipine

06

What researchers measure

Primary outcomes

  1. Exercise capacity

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

    Time frame: 9 months

Secondary outcomes

  1. Sublingual Nitrate

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

    Time frame: 1month and 3 months

  2. Biomarkers

    To evaluate the change of biomarkers against no CCB group at 9 months

    Time frame: 9 months

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01120327
Lead sponsor
Seoul National University Hospital
Responsible party
Hyo-Soo Kim (Investigator, Seoul National University Hospital) — Principal investigator
First posted
May 10, 2010
Start date
Sep 2011
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Apr 27, 2026

Study contacts

Hyo-Soo Kim, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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