| CTRI Number |
CTRI/2009/091/000429 [Registered on: 09/07/2010] |
| Last Modified On: |
12/03/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
|
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Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
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A clinical trial to study effects of Ivabradine® when given in combination with Atenolol® for patients with Chronic Stable Angina. |
Scientific Title of Study
Modification(s)
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A Phase IV, multi-centre, open label, comparative, parallel, randomized,
observational study to compare the efficacy, safety and tolerability of
Ivabradine® 5 mg (titrated to 7.5 mg after Day 30) administered along
with Atenolol® 50 mg versus Atenolol® 50 mg administered alone in
patients with Chronic Stable Angina |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| Protcol No: KL-LUPIVA-0050609 |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Satyendra Tewari |
| Designation |
|
| Affiliation |
|
| Address |
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
091-522-2668700 |
| Fax |
091-522-2668017 |
| Email |
stewari_sgpgi@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Alok Chaturvedi |
| Designation |
|
| Affiliation |
General Manager- Medical Services |
| Address |
Laxmi Towers,C wing,4th Floor
Bandra-Kurla Complex
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022-66402222 |
| Fax |
022-66402207 |
| Email |
alokchaturvedi@lupinpharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Alok Chaturvedi |
| Designation |
|
| Affiliation |
|
| Address |
Laxmi Towers,C wing,4th Floor
Bandra-Kurla Complex
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022-66402222 |
| Fax |
022-66402207 |
| Email |
alokchaturvedi@lupinpharma.com |
|
Source of Monetary or Material Support
Modification(s)
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Primary Sponsor
Modification(s)
|
| Name |
Lupin Limited |
| Address |
4Th Floor, Laxmi Tower, B Wing, Bandra Kurla Complex, Bandra East, Mumbai - 400051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Karmic Lifesciences |
|
|
Countries of Recruitment
Modification(s)
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India |
Sites of Study
Modification(s)
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| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VSPrakash |
Cardiology Clinic |
#503,8th Main, ,sadashivnagar-560080
Bangalore
KARNATAKA |
080-23618860
drprakashvs@gmail.com |
| Dr. R. Jairam Iyer |
Chandulal Chandrakar Memorial Hospital |
Nehru Nagar Chowk,G.E. Road, -490020
|
(0788)2294712
(0788)2292241
sujatajairam@hotmail.com |
| Mr. Akhil Shrivastav |
SGPGI-Lucknow |
,-
Lucknow
UTTAR PRADESH |
0522-26687000
0522-2668017
akhil@sgpgi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Alert IEC |
Approved |
| Alert IEC |
Approved |
| SGPGIMS |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Stable Angina, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Atenolol |
50mg OD for 90 Days |
| Comparator Agent |
Atenolol |
50mg OD for 90 Days |
| Intervention |
Ivabradine |
5mg BD for 30 days,
7.5mg BD for 60 days |
|
Inclusion Criteria
Modification(s)
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| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
• Male or Female patients > 18 years and ≤ 75 years of age.
• Patients with Chronic Effort Angina Pectoris for atleast 3 months prior to inclusion.
• Patients with Normal Sinus Rhythm on ECG at Screening.
• Patients undergoing treatment with Atenolol® or other beta-blocker agents for atleast 3 months.
• Patients with Positive Exercise Tolerance Test (ETT) at Screening.
• Patients who have signed Written Informed Consent.
|
|
| ExclusionCriteria |
| Details |
• Male or Female patients < 18 years and > 75 years of age.
• Resting Heart Rate of < 60 bpm as shown in ECG
• Unstable Angina, Prinzmetal’s Angina or Microvascular Angina.
• Recent acute myocardial infarction, coronary bypass surgery (less than 3 months before inclusion) or coronary angioplasty (less than 6 months before inclusion).
• Known high-grade left main coronary artery disease that has not been surgically bypassed or mechanically improved.
• Patient who cannot perform Exercise Tolerance Test (ETT).
• ECG abnormalities that would confound ETT interpretation.
• Clinically significant heart disease other than coronary artery disease.
• Congestive heart failure stage III or IV NYHA.
• Symptomatic hypotension.
• Uncontrolled hypertension (systolic blood pressure at rest > 180 mmHg or diastolic blood pressure at rest > 100 mmHg).
• Atrial fibrillation, flutter, pacemaker or cardioverter-defibrillator implantation.
• Patients with Hepatic disorders (ALT > 3 times normal value).
• Patients with Thyroid disorders.
• Patients with kidney disorders, renal failure (Serum Creatinine level > 180 µmol/l).
• Patients with Anaemia (Haemoglobin < 10 g/l).
• Any treatment with unauthorized concomitant medication during the study.
• Treatment with Bepridil® within 7 days prior to selection.
• Treatment with Amiodarone® within 3 months prior to selection.
• Contraindication to Ivabradine®: Second and third degree atrioventricular block, or sick sinus syndrome.
• Contraindication to Atenolol®: Second and third degree heart block, manifested heart failure, cardiogenic shock.
• History of any serious infectious disease like Hepatitis B or C, HIV etc.
• History of severe psychiatric or behavioural disorders likely to interfere with the study.
• History of serious abnormal drug reaction.
• History of any ophthalmic abnormality as found during screening.
• Pregnant and lactating women.
• Patients with other severe disease likely to interfere with the study in the investigator’s judgment.
• Use of investigational drug within 30 days of pre-selection, or concurrent therapy with an investigational drug(s).
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Method of Generating Random Sequence
Modification(s)
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Computer generated randomization |
Method of Concealment
Modification(s)
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Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
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Open Label |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
| Change in Total Exercise Duration (TED) on Exercise Tolerance Test (ETT) from |
Baseline (Day 0) to End of treatment (Day 90) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Change in other Exercise Tolerance Test (ETT) parameters including Time to Limiting Angina (TLA), Time to Onset of Angina (TOA), Time to 1-mm ST depression (TST) from Baseline to Day 90 (End of treatment)
• Change in Heart Rate as measured in beats per min (bpm) from Day 0 (Baseline) to Day 90 (End of treatment).
• Change in frequency of anginal attacks
• Change in need for anti-anginal rescue medication
|
|
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Target Sample Size
Modification(s)
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Total Sample Size="230"
Sample Size from India="230"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
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Phase 4 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
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|
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
This is a phase IV, multi-centre, open label, comparative, parallel, randomized, observational study to compare the efficacy, safety and tolerability of Ivabradine® 5mg (titrated to 7.5 mg after Day 30) administered along with Atenolol® 50 mg versus Atenolol® 50 mg administered alone in patients with Chronic Stable Angina. A study will be conducted in 3 centres in India. Primary end-point of the study is change in Total Exercise Duration (TED) from baseline to end of treatment on Exercise Tolerance Test (ETT). Secondary end-points of the study are Change in other Exercise Tolerance Test (ETT) parameters including Time to Limiting Angina (TLA), Time to Onset of Angina (TOA), Time to 1-mm ST depression (TST) from Day 0 (Baseline) to Day 90 (End of Treatment), Change in frequency of anginal attacks,Need for anti-anginal rescue medications, Change in Heart Rate as measured in beats per min (bpm) from Day 0 (Baseline) to Day 90 (End of treatment). |