drugset / Trial / NCT01396395
Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina
Phase 4
Completed
402 enrolled
Merck KGaA, Darmstadt, Germany
Merck Serono Co., Ltd., China · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study of 402 cases of stable angina subjects who were diagnosed as Coronary Heart Disease (CHD) is a randomized, blank controlled, multi-center clinical study. Subjects who are taking standard treatment with stable symptoms will receive a 24-hour ambulatory electrocardiogram (ECG) (Holter) examination. They will be randomly divided into two groups. The nicorandil group will receive nicorandil 5 milligram (mg) (3 times a day = tid) on top of the standard treatment for 12 weeks, while the control group will stay on standard treatment. Nitrates and beta blockers need to be maintained on a stable dose. Other drugs that do not affect the primary endpoint may be adjusted per investigators decision.
Timeline
- Start
- 2011-09
- Primary completion
- 2014-05
- Completion
- 2014-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicorandil | Other / unclassified | 5 mg | Oral |
| Background | Aspirin | Small molecule | — | — |