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Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina

Coronary Disease Clinical Trial

Official title:
A Prospective, Multi-center, Random, Open-label Research on Nicorandil Treatment of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina

Clinical Trial Summary

This study of 403 cases of stable angina patients who were diagnosed as Coronary Heart Disease (CHD) is a randomized, blank controlled, multi-center clinical study. Patients who are taking standard treatment with stable symptoms will receive a 24-hour ambulatory ECG (Holter) examination and whose results are positive will go into the treatment period. They will be randomly divided into two groups. The nicorandil group will receive nicorandil 5mg (3 times a day = tid) on top of the standard treatment for 3 months, 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01396395
Study type Interventional
Source Merck KGaA
Contact
Status Completed
Phase Phase 4
Start date July 2011
Completion date May 2014
View Details
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