Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02623569
Status:
UNKNOWN
Last Update Posted:
2015-12-07
First Post:
2015-11-29
Brief Title:
To Assess the Anti-anginal Safety and Efficacy of Ivabradine in Subjects With StableSymptomatic Chronic Angina
Sponsor:
Xintong Pharmacy Company
Organization:
Xintong Pharmacy Company
Study Overview
Official Title:
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
Status Verified Date:
2015-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Arms Assigned Interventions
Experimental Ivabradine Ivabradine 5 mg twice a day for first 4 weeks and 75mg twice a day when positive ETT and HR60timesmin or negative ETT and HR80timesmin of subjects
Active Comparator Atenolol Atenolol 125 mg twice a day for first 4 weeks and 25mg twice a day when positive ETT and heard rate60timesmin or negative ETT and HR 80timesmin of subjects
Experimental Ivabradine Ivabradine 5 mg twice a day for first 4 weeks and 75mg twice a day when positive ETT and HR60timesmin or negative ETT and HR80timesmin of subjects
Active Comparator Atenolol Atenolol 125 mg twice a day for first 4 weeks and 25mg twice a day when positive ETT and heard rate60timesmin or negative ETT and HR 80timesmin of subjects
Detailed Description:
1 Washout periodChronic angina patients stop using medicine that affect heart rate The patients undergoes ETT after 2-7 days and positive ETT into the treatment periodIf not take similar medicine patients can be carried out ETT directly
2 Treatment periodPatients carried out ETT after therapy with Ivabradine5mgbid Atenolol125mgbid for 4 weeksThe dose adjust base on test result and heart rate Ivabradine5mgbidAtenolol125mgbid or Ivabradine75mgbid Atenolol25mgbid for 8 weeks and carried out ETT
3 security periodAfter the treatment period all patients to take Atenolol 125mg 25mg bid 1 week
If heart rate are low 50 timesmin after taking Ivabradine 5mg Atenolol 125mg subjects should withdrawal and dropped out study If subjects heart rate are low 50 timesmin after taking Ivabradine 75mg Atenolol 25mg subjects should change the dose to Ivabradine 5mg Atenolol 125mg
2 Treatment periodPatients carried out ETT after therapy with Ivabradine5mgbid Atenolol125mgbid for 4 weeksThe dose adjust base on test result and heart rate Ivabradine5mgbidAtenolol125mgbid or Ivabradine75mgbid Atenolol25mgbid for 8 weeks and carried out ETT
3 security periodAfter the treatment period all patients to take Atenolol 125mg 25mg bid 1 week
If heart rate are low 50 timesmin after taking Ivabradine 5mg Atenolol 125mg subjects should withdrawal and dropped out study If subjects heart rate are low 50 timesmin after taking Ivabradine 75mg Atenolol 25mg subjects should change the dose to Ivabradine 5mg Atenolol 125mg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None