| CTRI Number |
CTRI/2010/091/001490 [Registered on: 26/10/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
A clinical trial to study the effects of Fixed-dose combination capsules of Rosuvastatin 10 mg and Aspirin 150 mg with Rosuvastatin 10 mg alone in patients with dyslipidemia |
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Scientific Title of Study
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A Multicentric, Open-Label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Safety and Efficacy of Fixed-dose combination capsules of Rosuvastatin 10 mg and Aspirin 150 mg with Rosuvastatin 10 mg alone in patients with dyslipidemia |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GKM/CT/Rosu_Asp/082010 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Nitin Rathod |
| Designation |
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| Affiliation |
|
| Address |
R.N.Cooper Hospital, Vileparle west, Mumbai
Mumbai
MAHARASHTRA
400057
India |
| Phone |
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| Fax |
|
| Email |
nitinmr@yahoo.in |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Nitin Rathod |
| Designation |
|
| Affiliation |
|
| Address |
R.N.Cooper Hospital, Vileparle west, Mumbai
Mumbai
MAHARASHTRA
400057
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
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Details of Contact Person
Public Query
|
| Name |
Dr. Nitin Rathod |
| Designation |
|
| Affiliation |
|
| Address |
R.N.Cooper Hospital, Vileparle west, Mumbai
Mumbai
MAHARASHTRA
400057
India |
| Phone |
|
| Fax |
|
| Email |
nitinmr@yahoo.in |
|
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Source of Monetary or Material Support
|
| M/s. GKM New Pharma
Spl Site No.: 5 to 8,
PIPDIC Electronic Park,
Thirubuvanai, Mannidipet Commune,
Pudhucherry - 605 107
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Primary Sponsor
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| Name |
M/s. GKM New Pharma |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rajiv R Oza |
Clinic, Bhavnagar, Rajivoza59@hotmail.com |
Clinic, Bhavnagar, Rajivoza59@hotmail.com,-
Bhavnagar
GUJARAT |
Rajivoza59@hotmail.com |
| Dr. Kirti C Patel |
KEM Hospital, Mumbai, pkirtic@yahoo.in |
KEM Hospital, Mumbai, pkirtic@yahoo.in,-
Mumbai
MAHARASHTRA |
pkirtic@yahoo.in |
| Dr. Raj G Bhagat |
NHL Medical College & Hospital, Ahmedabad, Rajpurvi@yahoo.com |
NHL Medical College & Hospital, Ahmedabad, Rajpurvi@yahoo.com,-
Ahmadabad
GUJARAT |
Rajpurvi@yahoo.com |
| Dr. Nitin M Rathod |
R. N. Cooper Hospital, Vileparle west, Mumbai, nitinmr@yahoo.in |
R. N. Cooper Hospital, Vileparle west, Mumbai, nitinmr@yahoo.in,-
Mumbai
MAHARASHTRA |
nitinmr@yahoo.in |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Dyslipidemia, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Fixed-dose combination capsules of Rosuvastatin 10 mg and Aspirin 150 mg |
10 mg and 150 mg |
| Comparator Agent |
Rosuvastatin 10 mg tablet |
10mg |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
Male and female outpatients ³ 18 but < 75 years of age.
1. Patients with dyslipidemia meeting the following criteria.
a. LDL Cholesterol > 130 mg/dL.
b. Serum Triglycerides > or equal to 150 mg/dL and < or equal to 500 mg/dL.
2. Able to stop current statin therapy without risk to the patient.
3. Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.
4. Patients who are able to adequately maintain the diary.
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| ExclusionCriteria |
| Details |
1. Not willing to sign the ICF,
2. Hypersensitivity to statins.
3. Serum Triglyceride levels > 500 mg/dL
4. Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator.
5. Patients with significant hepatic disease (liver function tests x 2 upper limit of normal reference range) or significant renal disease (creatinine x 2 upper limit of normal reference range).
6. Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes mellitus requiring insulin therapy
7. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney
8. Patients familiar with muscular pain, myopathy
9. History of drug or alcohol dependency within the previous six months. Chronic administration of any medication known to affect blood pressure, other than the trial medication
10. Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form.
11. Symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF III-IV) - unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three months prior to informed consent
12. Stroke less than six months prior to informed consent
13. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator.
14. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of Rosuvastatin
15. Patients with concomitant diseases such as malignancy, HIV
16. Pregnancy and lactation
17. History of pancreatitis
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| o Change from baseline values of LDL-C at the last visit at 12 weeks.
o Change from baseline values of serum triglycerides at the last visit at 12 weeks
o Change from baseline values of HDL-C at the last visit at 12 weeks
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12 weeks |
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Secondary Outcome
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| Outcome |
TimePoints |
| o Achievement of target levels of total cholesterol and LDL-cholesterol
o Number of patients achieving target levels of lipid levels ? treatment responders
o Patient compliance.
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12 weeks |
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Target Sample Size
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Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/09/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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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
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This study is A Multicentric, Open-Label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Safety and Efficacy of Fixed-dose combination capsules of Rosuvastatin 10 mg and Aspirin 150 mg with Rosuvastatin 10 mg alone in patients with dyslipidemia that will be conducted in four centres in India |