A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo
Amlodipine
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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)
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Amlodipine
Placebo
Arm Description
Amlodipine
Placebo
Outcomes
Primary Outcome Measures
Exercise capacity
Difference of the peak oxygen uptake change (VO2 max, mL/kg/min)
Secondary Outcome Measures
Sublingual Nitrate
To evaluate the change of sublingual nitrate use per day against no CCB group at 1 and 3 months
Biomarkers
To evaluate the change of biomarkers against no CCB group at 9 months
Full Information
NCT ID
NCT01120327
First Posted
April 30, 2010
Last Updated
May 7, 2010
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01120327
Brief Title
A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients
Official Title
A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
SUBJECTS AND CENTERS 212, stable angina patients with angiographically confirmed significant residual stenosis 10, 3rd-grade, teaching hospitals in Korea
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
212 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Amlodipine
Arm Type
Experimental
Arm Description
Amlodipine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
Amlodipine
Primary Outcome Measure Information:
Title
Exercise capacity
Description
Difference of the peak oxygen uptake change (VO2 max, mL/kg/min)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Sublingual Nitrate
Description
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
Title
Biomarkers
Description
To evaluate the change of biomarkers against no CCB group at 9 months
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hae-Young Lee, MD, PhD
Phone
82-10-4528-6160
Email
hylee612@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo-Soo Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hae-Young Lee, MD, PhD
Phone
82-10-4528-6160
Email
hylee612@snu.ac.kr
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients
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