| CTRI Number |
CTRI/2011/05/001744 [Registered on: 16/05/2011] Trial Registered Retrospectively |
| Last Modified On: |
02/12/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Phase 3, Registration Clinical Study to Evaluate the Efficacy and Safety of Colesevelam Hydrochloride as Combination Therapy in Adult Indian Non Diabetic Patients with Primary increased lipid level & Type II Diabetic Patients with Primary increased lipid level |
Scientific Title of Study
Modification(s)
|
A Phase 3, Multi Centre, Open label, Parallel, Two Groups, Multi Arm, Randomized, Registration Clinical Study to Evaluate the Efficacy and Safety of Colesevelam Hydrochloride as Combination Therapy in Adult Indian Non Diabetic Patients with Primary Hyperlipidemia & Type II Diabetic Patients with Primary Hyperlipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2010IND001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chakrapani Bhardwaj |
| Designation |
consultant Physician and cardiologist |
| Affiliation |
|
| Address |
3/1140,
Vasundhra,
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
0120-2698167 |
| Fax |
|
| Email |
drchakrapanibhardwaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Hardeep Wadwa |
| Designation |
|
| Affiliation |
Head of R&D |
| Address |
Ind-Swift Ltd, HO: SCO850, Shivalik Enclave,
NAC, Manimajra,
Chandigarh
CHANDIGARH
160101
India |
| Phone |
0172-2730503 |
| Fax |
0172-2730504 |
| Email |
hardeepwadhwa@sify.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Ms Naga Anand |
| Designation |
Chief Executive Officer |
| Affiliation |
Consortium Clinical Research Pvt. Ltd., |
| Address |
9/41, Sri Kalki Gardens,Sugunapuram, Kuniyamuthur (Po), Coimbatore
Coimbatore
TAMIL NADU
641008
India |
| Phone |
0422-3261222 |
| Fax |
|
| Email |
naga@consortiumcr.com |
|
|
Source of Monetary or Material Support
|
| Ind-Swift Ltd., Head Office: SCO 850, Shivalik Enclave, NAC, Manimajra, Chandigarh-160101, India. |
|
|
Primary Sponsor
|
| Name |
IndSwift Ltd Head Office SCO Shivalik Enclave NAC Manimajra Chandigarh India |
| Address |
Ind-Swift Ltd.,
Head Office: SCO850, Shivalik Enclave,
NAC, Manimajra,
Chandigarh-160101, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suman R |
Madhumeha (Diabetes education & treatment Centre) |
Madhumeha (Diabetes education & treatment Centre)
No.375, 42nd Cross, 8th Block
Jayanagar, Bangalore-560082
Bangalore
KARNATAKA |
08026638254
-
sumangowda@hotmail.com |
| Dr Sumant Gupta |
Mangal Gastro Clinic |
Mangal Gastro Clinic
Indrapuram, Ghaziabad
Ghaziabad
UTTAR PRADESH |
09818628242
-
drsumantgupta@gmail.com |
| Dr Chakrapani Bahrdwaj |
Sandhya Medical Chamber |
3/1140, ,Vasundhra,-201012
Ghaziabad
UTTAR PRADESH |
0120-2698167
drchakrapanibhardwaj@gmail.com |
| Dr Niroop |
Sarvodaya Hospital |
11/2, Agrahara Dasarahalli,,Magadi Main Road,-560079
Bangalore
KARNATAKA |
080-43326000
nirrup@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MagPower Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Non Diabetic Patients with Primary Hyperlipidemia & Type II Diabetic Patients with Primary Hyperlipidemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Colesevelam Hydrochloride |
625mg, 3 tablets twice daily per oral for 28 Weeks |
| Comparator Agent |
Statin & Metformin |
Statin: 10mg, once daily & Metformin: 850mg, twice daily per oral for 28 Weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria for Group A & B:
1.Male or female patients of 18 to 75 years of age (both inclusive).
2.LDL-C ≥ to 115 mg/dL and to 250 mg/dL.
3.TG ≤ to 300 mg/dL.
4.Women who are not pregnant or breast-feeding or planning to become pregnant.
5.Women of child-bearing potential had a hysterectomy or tubal-ligation, or Women of post menopausal stage or who practice the use of contraceptives other than oral contraceptives.
Inclusion Criteria for Group B (in addition to that of Group A):
6.HbA1C% ≥ 7.5 and ≤ 9.5% |
|
| ExclusionCriteria |
| Details |
1.Patients with known history of Type 1 Diabetes Mellitus.
2.History of acute or chronic metabolic acidosis, including diabetic ketoacidosis.
3.Patients with known history of Fredrickson Type I, III, IV and V dyslipidemias.
4.Acute coronary syndrome (e.g., myocardial infarction or unstable angina), coronary intervention (coronary artery bypass graft or percutaneous transluminal coronary angioplasty or similar procedure), congestive heart failure (requiring pharmacological treatment), or transient ischemic attack within 3 months of screening visit.
5.Patients with any vitamin deficiencies.
6.Patients with a history of bowel obstruction.
7.Patients with a history of major gastrointestinal surgery.
8.Patients with a history of Hyper Triglyceridemia-induced pancreatitis.
9.Patients with any malabsorbtion syndromes.
10.Patients suffering from seizures.
11.Patients suffering with constipation (including fecal impaction problems).
12.Patients with gastrointestinal motility disorders (including gastroparesis).
13.Patients suffering from Dyspepsia.
14.Patients suffering from Nausea.
15.Patients suffering from Dysphagia.
16.Patients suffering from esophageal obstruction.
17.Patients with serum creatinine concentration of > 2.0 mg / dl.
18.Patients with alanine transaminase concentration of > 2.5 time the upper limit of normal.
19.Patients with aspartate transaminase concentration of > 2.5 time the upper limit of normal.
20.Patients with a creatine kinase concentration > 3 time the upper limit of normal.
21.Patients currently on any drug with a narrow therapeutic index.
22.Patients currently on Thiazolidinediones.
23.Patients currently on dipeptidyl peptidase 4 indicators.
24.Patients currently on any oral vitamin supplements.
25.Patients currently on cyclosporine.
26.Patients currently on glyburide.
27.Patients currently on levothyroxine.
28.Patients currently on Warfarin.
29.Patients currently on thyroid replacement therapy.
30.Female patients currently on oral contraceptives containing ethinylestradiol and norethindrone.
31.Known hypersensitivity to Statins.
32.Known hypersensitivity to Metformin HCl.
33.Patients with a fasting plasma glucose concentration > 300 mg/dl.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Group A
1.To determine the Efficacy of Colesevelam Hydrochloride in combination with Statin when compared with Statin in patients with Primary Hyperlipidemia.
Group B
1.To determine the Efficacy of Colesevelam Hydrochloride in combination with Metformin and Statin when compared with Statin and Metformin in Type II diabetic patients with Primary Hyperlipidemia. |
Group A
At the end of 6-week period.
Group B
At the end of 26-week period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Group A
1.To determine the Safety of Colesevelam Hydrochloride in combination with Statin when compared with Statin in patients with Primary Hyperlipidemia.
Group B
1.To determine the Safety of Colesevelam Hydrochloride in combination with Metformin and Statin when compared with Statin and Metformin in Type II diabetic patients with Primary Hyperlipidemia. |
Group A
At the end of the 6-week period.
Group B
At the end of the 26 week period. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/04/2011 |
| 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
|
Years="0"
Months="4"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
There will be 2 groups - Group A: Primary Hyperlipidemia Patients with or without Type II Diabetes & Group B: Type II Diabetic Patients with Primary Hyperlipidemia) and 4 arms in this study. Two arms are the Test arms (Arm A & Arm C), while the other 2 arms are Reference Arms (Arm B & Arm D). The non-diabetic patients with primary hyperlipidemia will be enrolled in either Arm A / B and the type II diabetic patients with primary hyperlipidemia will be enrolled in either Arm C / D as per the randomization schedule. Patients in arm A will receive Colesevelam Hydrochloride + Statin, patients in arm B will receive Statin alone, patients in arm C will receive Colesevelam Hydrochloride + Metformin + Statin and patients in arm D will receive Metformin + Statin alone. The study duration for the Non Diabetic and diabetic patients with Primary Hyperlipidemia will be 6 weeks and treatment will be continued for Type II diabetic patients up to 26 weeks. For Group A, there are totally 4 visits which comprises of Screening, Baseline, Day 14 & Day 42. For Group B there are totally 9 visits which comprises of Screening, Baseline, Day 14, Day 42, Day 70, Day 98, Day 126, Day 154 & Day 182. All other safety & efficacy parameters for both the groups will be performed as per the schedule. |