Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 55 of 117 for:    Atenolol

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02623569
Recruitment Status : Unknown
Verified December 2015 by Xintong Pharmacy Company.
Recruitment status was:  Recruiting
First Posted : December 7, 2015
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Xintong Pharmacy Company

Tracking Information
First Submitted Date  ICMJE November 29, 2015
First Posted Date  ICMJE December 7, 2015
Last Update Posted Date December 7, 2015
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2015)
The primary efficacy endpoint is Change from total exercise duration in exercise tolerance test (ETT) [ Time Frame: Baseline and end of treatment (Week 12) . ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2015)
  • Time to angina in exercise tolerance test. [ Time Frame: 12 weeks ]
  • Time to 1 mm ST-segment depression in exercise tolerance test [ Time Frame: 12 weeks ]
  • Number of angina attacks in exercise tolerance test per week [ Time Frame: 12 weeks ]
  • Number of sublingual nitroglycerin consumption per week [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Assess the Anti-anginal Safety and Efficacy of Ivabradine in Subjects With Stable,Symptomatic Chronic Angina
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Angina Pectoris
Intervention  ICMJE
  • Drug: Ivabradine
    Not Provided
    Other Name: Not Provided
  • Drug: Atenolol
    Not Provided
    Other Name: Not Provided
Study Arms  ICMJE
  • Experimental: Ivabradine
    Ivabradine 5 mg twice a day for first 4 weeks and 7.5mg twice a day when positive ETT and HR(heard rate)>60times/min or negative ETT and HR(heard rate)>80times/min of subjects.
    Intervention: Drug: Ivabradine
  • Active Comparator: Atenolol
    Atenolol 12.5 mg twice a day for first 4 weeks and 25mg twice a day when positive ETT and HR(heard rate)>60times/min or negative ETT and HR (heard rate)>80times/min of subjects.
    Intervention: Drug: Atenolol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 4, 2015)
336
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. male or female aged 18 to 75 years
  2. Clearly understand the study and participate in it voluntarily; the informed consent should be signed in person or by legal guardian.
  3. Chronic Stable Angina was confirmed by clinic over 3 months.
  4. Patients with clinical diagnosis of chronic stable angina and must meet one of the following conditions:

    • Patients who have a history of myocardial infarction over 3 months.
    • Patients who have received coronary intervention or CABG(Coronary Artery Bypass Grafting) over 6 months.
    • Stenosis of more than 50% in at least one major epicardial coronary artery shown by Coronary Angiograph.
    • Ischemic electrocardiogram changes:ST-segment depression ≥ 1.0 mm compared with P-R or elevate≥1.0 mm during exercise ECG Computed Tomography Angiography (CTA) showed more than 50% stenosis with typical angina symptoms
  5. ultrasonic cardiogram disclosed that left ventricular ejection fraction ≥50 %.
  6. Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) at screening.

Exclusion Criteria:

  1. Clinically significant Valvular disease, congenital heart disease, pulmonary hypertension, cerebral apoplexy, dissecting aneurysm, hypertrophic cardiomyopathy, acute myocarditis/cp.
  2. Patients with myocardial infarction within the preceding 3 months
  3. Patients have received Coronary angioplasty or CABG within the preceding 6 months.
  4. Patients who have severity vessels disease with left main coronary artery but have no valid treatment.
  5. Patients with congestive heart failure(New York Heart Association class III or IV)or acute pulmonary edema.
  6. Patients whose rest heart rate< 60 bpm.
  7. Patients with nonrespiratory sinus arrhythmia or arrhythmia(e.g.,AVB(auriculo-ventricular block)ⅡⅢ,atrial fibrillation,atrial flutter,SSS(sick sinus syndrome)) or implantable cardiac defibrillator (ICD).
  8. Patient with any conditions that interfered the performance of exercise tolerance test or a history of an abnormal exercise response limited by electrocardiograph (ECG) changes.
  9. Patient with uncontrolled hypertension (seated systolic blood pressure (SBP)≥180 mmHg or diastolic blood pressure (DBP) ≥100 mmHg); SBP<90 mmHg and/or DBP<60 mmHg
  10. Diabetic with uncontrolled blood glucose(FBG≥11.1 mmol/L and/or RBG≥13.6 mmol/L)
  11. Patients with anemia(male:Hb≤120 g/L;female:Hb≤110 g/L)
  12. Patients complicated with systemic diseases included thyroid dysfunction、glaucoma、cataract,neurological、mental、psychological disease and any other disease that influence the judgment.
  13. Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.).
  14. Patients with mental or legal disorder.
  15. Patients who were suspected addicted into alcohol or drug abuse or with severe complications that would make the condition more complicated assessed by the investigator.
  16. People have liver or renal dysfunction (ALT≥2×ULN、AST≥2×ULN、eGFR≤60ml/min/1.73m2)
  17. Patients who should use unapproved drug during the study.
  18. Patients who accepted amiodarone(in recent 3 months)and/or benzetimide、βblockers(in recent 7 days)、
  19. Patients with history of allergy or suspected allergic to the drug(e.g.,Hydrochloric ivabradine,atenolol, βblockers)or lactose.
  20. Woman who disagree with contraception during treatment period ,with pregnancy, lactation or positive result of pregnancy test.
  21. Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators.
  22. Patients who is participating in other trials or has been participated in other trials in recent 3 months
  23. Patients who were unable to participate in the study as judged by investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02623569
Other Study ID Numbers  ICMJE A130901CSPF01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xintong Pharmacy Company
Study Sponsor  ICMJE Xintong Pharmacy Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Xintong Pharmacy Company
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP