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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01120327
• Other study ID #: Amlodipine study
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 30, 2010
• Last updated: May 7, 2010
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2010
• Source: Seoul National University Hospital
• Contact: Hae-Young Lee, MD, PhD
• Phone: 82-10-4528-6160
• Email: hylee612[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 212
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Placebo
Placebo
• Amlodipine
Amlodipine

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity	Difference of the peak oxygen uptake change (VO2 max, mL/kg/min)	9 months	No
Secondary	Sublingual Nitrate	To evaluate the change of sublingual nitrate use per day against no CCB group at 1 and 3 months	1month and 3 months	Yes
Secondary	Biomarkers	To evaluate the change of biomarkers against no CCB group at 9 months	9 months	Yes