| CTRI Number |
CTRI/2009/091/001022 [Registered on: 18/12/2009] |
| Last Modified On: |
27/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of Atorvastatin + Ramipril + Aspirin +
Metoprolol (as extended release) fixed dose combination capsules for secondary prophylaxis in patients with ischemic heart disease. |
Scientific Title of Study
Modification(s)
|
An open label multicentric study to assess the efficacy and safety of Atorvastatin + Ramipril + Aspirin + Metoprolol (as extended release) fixed dose combination capsules for secondary prophylaxis in patients with ischemic heart disease. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 09-16 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower,
Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd
Zydus Tower
Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
|
| Address |
Cadila Healthcare Ltd
Zydus Tower
Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Cadila Healthcare Ltd. Ahmedabad, India. |
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Ltd |
| Address |
Zydus Tower,
Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Mahendra Parmar |
Government Medical College, Vadodara |
Dept. of Medicine,Government Medical College-
Vadodara
GUJARAT |
mcparmar1961@yahoo.co.in |
| Dr Puneet Rijhwani |
Mahatma Gandhi National Institute of Medical Sciences Jaipur |
Dept. of Medicine Mahatma Gandhi National Institute of Medical Sciences
Jaipur
RAJASTHAN |
9314503514
puneet284@rediffmail.com |
| Dr. Raghvindra Chowdhary |
S.P. Medical College and A.G. Hospitals, Bikaner. |
Dept. of Medicine,S.P. Medical College and A.G. Hospitals-
Bikaner
RAJASTHAN |
drraghven_10@yahoo.com |
| Dr. Praveen Garg |
Shashwat Hospital & Research Centre, Ahmedabad |
Consultant Physician, Shashwat Hospital & Research Centre,,323, Satyam Mall, Opposite Vishweshwar Mahadev Temple, Mansi Cross Road, Vastrapur,-
Ahmadabad
GUJARAT |
079-26741500
praveen_k_garg@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee - S.P. Medical College and A.G. Hospitals, Bikaner |
Approved |
| Independent Ethics Committee - Aditya (DrMahendraParmarBaroda) |
Approved |
| Independent Ethics Committee - Aditya (DrPraveenGargAhmedabad) |
Approved |
| Institutional Ethics Committee - Mahatma Gandhi Medical College & Hospital, Jaipur (DrPuneetRijhwaniJaipur) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, Secondary prophylaxis of ischemic heart disease, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Fixed dose combination capsules of Atorvastatin 10mg + Ramipril 5mg + Aspirin 150mg + Metoprolol succinate 25mg (as extended release) |
Once daily in the evening for 4 weeks |
| Comparator Agent |
None |
Not applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex more than or equal to 18 years of age (No upper age limit was mentioned in our Protocol for this clinical trial).
2. Established diagnosis of ischemic heart disease.
3. Informed consent of the patient / relative. |
|
| ExclusionCriteria |
| Details |
1.Pregnancy & Lactation.
2.Patients with active liver disease or hepatic dysfunction indicated by AST or ALT levels 2.5 times the upper limit of normal.
3.Patients with history of myopathy or evidence of active muscle disease.
4.Patients with congestive heart failure (defined as New York Heart Association class III or IV heart failure).
5.Patients with 2nd or 3rd degree AV block, sick sinus syndrome or uncontrolled cardiac arrhythmias.
6.Patients with active peptic ulceration, hemophilia or hemorrhagic disorders.
7.Patients with unstable endocrine or metabolic diseases known to influence serum lipids and lipoproteins or known impairment of renal function.
8.Patients with any other serious concurrent illness or malignancy.
9.Patients with continuing history of alcohol and / or drug abuse.
10.Patients with known hypersensitivity to either of the contents of the combination.
11.Participation in another clinical trial in the past 3 months. |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| No. of events of manifestations of ischemic heart disease experienced by the patients during the study period of 4 weeks. |
0,2 & 4 weeks. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
(1) The reduction in the systolic and diastolic blood pressure at the end of the treatment phase i.e. Week 4, as compared to the start of the treatment phase i.e., Week 0.
(2) The percent change in serum LDL cholesterol and other lipid parameters at the end of the treatment phase i.e., Week 4, as compared to the start of the treatment phase i.e., Week 0.
(3) No. of tablets of isosorbide dinitrate taken by the patients during the study period of 4 weeks. |
0,2 & 4 weeks. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
26/11/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
“none yet†|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is an open label, multicentric study assessing the safety and efficacy of fixed-dose combination capsules of Atorvastatin 10mg + Ramipril 5mg + Aspirin 150mg + Metoprolol succinate 25mg (as extended release) once daily in the evening for 4 weeks for secondary prophylaxis in 100 patients with ischemic heart disease that will be conducted in one center only in India. The primary outcome measure will be the number of events of manifestations of ischemic heart disease experienced by the patients during the study period of 4 weeks. |