A TSHRN1201 Sub-study-To Evaluate the Effects of add-on Ranolazine on Exercise Tolerance and Angina Frequency

Angina Clinical Trial

Official title: A TSHRN1201 Sub-study-To Evaluate the Effects of add-on Ranolazine on Exercise Tolerance and Angina Frequency in Patients With Stable Angina Pectoris.

Status Completed

Clinical Trial Summary

This is a double-blind, randomized, placebo-controlled, and parallel study. The study is comprised of three main phases: a single-blind placebo run-in qualifying phase lasting about 14 days, a double-blind treatment phase of 12 weeks, and a 2-week follow-up phase. Approximately 18 patients will be enrolled and randomly assigned to receive placebo or 1,000 mg of extended-release Ranolazine twice-daily for 12 weeks to reach 14 evaluable patients at the end of the study.

Clinical Trial Description

This is a double-blind, randomized, placebo-controlled, and parallel study. The study is comprised of three main phases: a single-blind placebo run-in qualifying phase lasting about 14 days, a double-blind treatment phase of 12 weeks, and a 2-week follow-up phase. Approximately 18 patients will be enrolled and randomly assigned to receive placebo or 1,000 mg of extended-release Ranolazine twice-daily for 12 weeks to reach 14 evaluable patients at the end of the study.

Patients with chronic angina pectoris will be screened for eligibility after providing informed consent. Patients present with the symptoms of stable angina after withdrawn from other antianginal agents and given the required background therapy for at least 5 days will be qualified for entering this study and performing 1st ETT qualifying test. ;

Related Conditions & MeSH terms

• Angina
• Angina Pectoris

• NCT number: NCT03401502
• Study type: Interventional
• Source: TSH Biopharm Corporation Limited
• Status: Completed
• Phase: N/A
• Start date: June 7, 2018
• Completion date: March 31, 2019