NCT02623569

To Assess the Anti-anginal Safety and Efficacy of Ivabradine in Subjects With Stable，Symptomatic Chronic Angina

Evaluation of the Anti-anginal Efficacy and Safety of Ivabradine Used in Patients With Stable Effort Angina Pectoris. A 12 Weeks Randomised, Double-blind Controlled, Parallel-group, Multicentre Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Xintong Pharmacy Company · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Arms Assigned Interventions Experimental: Ivabradine Ivabradine 5 mg twice a day for first 4 weeks and 7.5mg twice a day when positive ETT and HR\>60times/min or negative ETT and HR\>80times/min of subjects. Active Comparator: Atenolol Atenolol 12.5 mg twice a day for first 4 weeks and 25mg twice a day when positive ETT and heard rate\>60times/min or negative ETT and HR \>80times/min of subjects.

Detailed description

1. Washout period：Chronic angina patients stop using medicine that affect heart rate. The patients undergoes ETT after 2-7 days and positive ETT into the treatment period(If not take similar medicine, patients can be carried out ETT directly)。 2. Treatment period：Patients carried out ETT after therapy with Ivabradine(5mg,bid)/ Atenolol(12.5mg,bid) for 4 weeks.The dose adjust base on test result and heart rate, Ivabradine(5mg,bid)/Atenolol(12.5mg,bid) or Ivabradine(7.5mg,bid)/ Atenolol(25mg,bid) for 8 weeks and carried out ETT. 3. security period：After the treatment period, all patients to take Atenolol 12.5mg/ 25mg bid 1 week. If heart rate are low 50 times/min after taking Ivabradine 5mg/ Atenolol 12.5mg, subjects should withdrawal and dropped out study. If subjects heart rate are low 50 times/min after taking Ivabradine 7.5mg/ Atenolol 25mg, subjects should change the dose to Ivabradine 5mg/ Atenolol 12.5mg.

Conditions

• Angina Pectoris

Interventions

Type	Name	Description
DRUG	Ivabradine	Not Provided
DRUG	Atenolol	Not Provided

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-12-07
• Last updated: 2015-12-07

Locations

3 sites across 1 country: China