| CTRI Number |
CTRI/2011/09/001989 [Registered on: 07/09/2011] Trial Registered Prospectively |
| Last Modified On: |
23/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical Trial to study the efficacy, safety and tolerability of Carvedilol Phosphate ER + Amlodipine Capsule Vs Amlodipine + Metoprolol Tablet in Patients with Mild to severe Heart Failure |
|
Scientific Title of Study
|
A Clinical trial to study the efficacy, safety and tolerability of Carvedilol Phosphate ER 10 mg + Amlodpine 5 mg Capsule Vs Amlodipine 5 mg + Metoprolol 50 mg Tablet in Patients with Mild to severe Heart Failure. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/10/035 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent
43 AB/44CD, Charkop Industrial Estate,Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent
43 AB/44CD, Charkop Industrial Estate,Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent
43 AB/44CD, Charkop Industrial Estate,Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent
43 and 44,ABCD,Charkop Industrial Estate,Kandivli (West)
Mumbai
MAHARASHTRA
400 067
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajiv Srivastava |
Criticare Superspeciality Hospital |
Consultant Cardiac Surgeon,
Criticare Superspeciality Hospital,
Between Hotel Royal Challenge II and Cadbury’s Limited,
Eastern Express Highway, Thane (W), 400604
Thane
MAHARASHTRA |
09892490089
rajiv0207@gmail.com |
| Dr Pandit Kishanrao Deshmukh |
Kuvam Clinic |
MD Medicine, Kuvam Clinic,
Sri Balaji Compound,
Maheshwari Talkies Road,
Adilabad -504001
Adilabad
ANDHRA PRADESH |
09550061402
ashavnee@yahoo.com |
| Dr Vishal Gupta |
Lifeline Hospital |
Consultant Physician,MD Medicine,
Lifeline Hospital,
6/7, First Floor, Shiv Dhara Complex,
Nr. H. P. Petrol Pump, Makarand Desai Marg, Vasna Road,
Vadodara 390021, Gujarat
Vadodara
GUJARAT |
09898571903
vishalgupta3637@yahoo.com |
| Dr Parthiv Dholakia |
Smt. S.C. & Seth D.M. Sarvajanik Hospital & Maternity Home |
Dept.of Medicine,
Smt. S.C. & Seth D.M. Sarvajanik Hospital & Maternity Home,
Gozaria - 382825, Dist. - Mehsana, Gujarat.
Mahesana
GUJARAT |
09426519834
dholakiapv@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jagruti Independent Ethics Committee Bandra Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I508||Other heart failure, Patients suffering from Mild to severe Heart Failure
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amlodipine + Metoprolol |
Amlodipine 5mg+ Metoprolol 50mg,
Route of Administration: Oral,Once daily for 12 Weeks |
| Intervention |
Carvedilol + Amlodipine |
Carvedilol 10mg + Amlodipine 5mg Capsule
Route of Administration: Oral
Once daily for 12 Weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or Female patients with age between 18 & 60 years
2.Patients with clinically diagnosis of Mild to severe Heart Failure
3.Written informed consent to participate to the trial. |
|
| ExclusionCriteria |
| Details |
1.Males or females, less than 18 or more than 60 years of age
2.History of hypersensitivity to the study drug or similar class of drug.
3.Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications.
4.Patients with serum creatinine greater than 2.5 mg/dl.
5.History of drug dependency, alcohol abuse, or serious neurological or psychological disease.
6.Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.
7.Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.
8.Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
i)Peripheral edema
2)dyspnea
3)jugular venous distension 4)nocturnal cough
5)pulmonary rales
6)Body weight
7)Ankle circumference |
At base line and end of 2nd, 4th,8th and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Global assessment of Safety and Tolerability by patients and physicians. |
At the end of 12th Week |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/09/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Comparative, Randomized, Open label, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Carvedilol Phosphate ER 10 mg + Amlodipine 5 mg Capsule Vs Amlodipine 5 mg + Metoprolol 50 mg Tablet in Patients with Mild to severe Heart Failure. The Study is proposed to start on 05.09.11. The following primary out come will be measured at baseline, 2nd week, 4th week, 8th week and 12th week: Change in Peripheral edema, dyspnea, jugular venous distension, nocturnal cough and pulmonary rales. Body weight and ankle circumference will be evaluated at each visit. The secondary outcome will be measured at the final visit (12th week) - overall response of clinical cure & overall global assessment (based on total score of signs & symptoms). |