| CTRI Number |
CTRI/2010/091/000054 [Registered on: 21/04/2010] |
| Last Modified On: |
06/12/2018 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Randomized Factorial Trial |
Public Title of Study
Modification(s)
|
The Indian Polycap-K Study (TIPS-K) |
|
Scientific Title of Study
|
A randomized double-blind 2x 2 factorial controlled trial of the efficacy and safety of low strength PolycapTM versus two doses of low strength PolycapTM and of low strength potassium supplementation in patients with stable cardio-vascular disease or ischemic heart disease. |
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Secondary IDs if Any
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| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Alben Sigamani |
| Address |
Division of Clinical Trials
St. Johns Research Institute, Kormangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08025523416 |
| Fax |
08025633382 |
| Email |
alben@sjri.res.in |
|
Details Contact Person
Scientific Query
|
| Name |
Dr. Alben Sigamani |
| Address |
Division of Clinical Trials
St. John's Research Institute, Kormangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08025523416 |
| Fax |
08025633382 |
| Email |
alben@sjri.res.in |
|
Details Contact Person
Public Query
|
| Name |
Dr Denis Xavier |
| Address |
Division of Clinical Trials
St. John's Research Institute, Kormangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08025523416 |
| Fax |
08025633382 |
| Email |
denis@sjri.res.in |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
Cadila Pharmaceuticals India Ltd. Cadila Corporate Campus', Sarkhej - Dholka Road, Bhat, Ahmedabad- 382210 |
| 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 |
|
Sites of Study
|
| No of Sites = 25 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Anil Dhall |
Artemis Health Institute |
sector-51,-122001
Gurgaon
|
0124 6767999
0124 6767701
anil@artemishealthsciences.com |
| Dr. Poonam Lavhe |
Avanti Hospital |
Abhiyankar Road,Dhantoli-440012
Nagpur
|
0712 2522408
0712 2461599
pons_gmc@yahoo.com |
| Dr. K. G. Alexander |
Baby Memorial Hospital |
Indira Gandhi road,-673 004
Not Applicable
|
0945 2723272
kga@babymhospital.org |
| Dr. Neeta Deshpande |
Belgaum Diadetes Center |
Bhandar Ground Floor,Maruti Galli Belgaum-590 001
Belgaum
|
083 2422668
0831 4215380
neetarohit@gmail.com |
| Dr. ketan Mehta |
Health Harmony Hospital |
2 dattani Chamber,S.V Road, Malad-400 064
Mumbai
|
022 28827500
022 28837500
kkmehta@gmail.com |
| S. Anandaraja |
Indira Gandhi Gov. General Hospital and Post Graduate Institute |
,-605001
Pondicherry
|
09488084379
s.anandaraja@gmail.com |
| Dr. Srinivas Prabhu |
Kempegowda Institute of Medical Sciences |
no. 17, Balaji Nilaya,,4th cross, kumara park west-560020
Bangalore
|
080 26715790
ncsprabhu@yahoo.co.in |
| Dr. Rajendra Kumar Premchand |
Krishna Institute of Medical Sciences |
1-8, 31/1,Minister road, Secunderabad-500 003
Hyderabad
|
040-44885363
040 27845555
kumarpre@hotmail.com |
| Dr. S. V. Kulkarni |
Kulkarni Nursing Home. Diabetes & Heart Care Center |
101-shree towers, sector 20,kharghar-410204
Mumbai
|
09521922636
02192 263683
drsvk123@rediffmail.com |
| Dr. Srinivasha Murthy |
Lifecare Clinic and Research Center |
No. 2253,M.C.N Complex, Kodigehalli-560092
Bangalore
|
080-41735500
080 23630055
lifecareclinic@rediffmail.com |
| Dr. Sandeep Kumar Gupta |
M.V. Hospital & Research Center |
Mirza Mandi chowk,-226003
Lucknow
|
0522 4079157
sandeepkumar.gupta@rediffmail.com |
| Dr. V. Mohan |
Madras Diabetes research Foundation |
Conram Smith Road ,Gopalapuram-600 086
Chennai
|
9840923632
044 28350935
clinicaltrial@mdrf.in |
| Dr. S.P. Kalantri |
Mahatma Gandhi Institute of Medical Sciences (MGIMS) |
Sevagram,-442 102
Wardha
|
9970168766
07152 284967
sp.kalantri@gmail.com |
| Dr. Sindhu Joshi |
Mahavir Hospital |
Bhagvan mahavir Marg,AC Guards-500 004
Hyderabad
|
040 23393134
040 23320447
dr_sindhu@yahoo.com |
| Dr. J. Narendra |
Nanjappa Hospital |
Nanjappa Hospital,kuvempu Road-577201
Shimoga
|
08182 221003
08182 225085
incardiology@gmail.com |
| Dr. Jagadish Hiremath |
Poona Hospital and Research Center |
hall Clinic 40,Sasoon Road-411 001
Pune
|
09822002441
020-24321991
jagdish_hiremath@vsnl.net |
| Dr. N. Chidambaram |
Rajamuthaiah Medical College and Hospital |
Annamalai Nagar,-608 002
Chennai
|
04144 238010
04144 233992
deanrmmc@yahoo.com |
| Dr. J. B. Gupta |
S. R. Kalla Memorial Gastro & General Hospital |
Dhuleshwar,Sardar patel marg-
Jaipur
|
014 5112042
0141 4020622
guptadrjp@rediffmail.com |
| Dr. Nakul Sinha |
Sanjay Gandhi Post Graduate Instituite of medical Sciences |
,-226 014
Lucknow
|
0522 2668004
0522 2668573
nsinha@sjpgmi.ac.in |
| Dr. Kamal Sharma |
Sanjeevani Super Speciality Hospital |
Vastrapur,-380015
Ahmadabad
|
09426020154
079 26307165
kamalsharma1975@rediffmail.com |
| dr. Khursid Iqbal |
Sher-I-Kashmir Institute of MEdical Sciences |
Soura,-659 011
Srinagar
|
0194 2401013
iqbal.khurshid@gmail.com |
| Dr. Harshawardhan Mardikar |
Spandan Heart Institute and research Center |
off Chitaley marg,Behind Hitavada press-440012
Nagpur
|
0712- 2443333
0712 6629691
drmardikar@spandanheart.com |
| Dr. Sanjay G |
Sree Chitra Tirunal Institute of Medical Sciences |
Trivandrum,-695 011
Not Applicable
|
9447799137
drsanjayganesh@yahoo.com |
| Dr. Ganapathi Bantwal |
St. John's medical College And Hospital |
St. John's Medical Collge and Hospital,Kormangala-560034
Bangalore
|
080- 9243104520
080 25635313
trialsclinical@gmail.com |
| Dr. Balraj Bosco |
Trichy Diabetes Speciality Center |
Shasthri Road,Thillai Nagar-620018
Not Applicable
|
04312742091- 94
0431 4021782
boscocity@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 25 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee Indira Gandhi Govt. general Hospital and Post Graduate Institute |
Approved |
| Intuitional Ethics Committee Krishna Institute of Medical Sciences |
Approved |
| Independent Ethics Committee BKS Hospital |
Approved |
| Independent Ethics Committee Health Harmony |
Approved |
| Independent Ethics Committee Kulkarani Nursing Home |
Approved |
| Independent Ethics Committee lifecare Clinic |
Approved |
| Independent Ethics Committee Najappa Hospital |
Approved |
| Independent Ethics Committee Trichy Diabetes Centre |
Approved |
| Independent Ethics CommitteeBelgaum Diabetes Centre |
Approved |
| Intuitional Ethics Committee Sanjeevani Hospital |
Approved |
| Intuitional Ethics Committee SGPGI |
Submittted/Under Review |
| Intuitional Ethics Committee Artemis Health Institute |
Approved |
| Intuitional Ethics Committee Avanti Hospital |
Submittted/Under Review |
| Intuitional Ethics Committee Baby Memorial Hospital |
Submittted/Under Review |
| Intuitional Ethics Committee Kempegowda Institute of Medical Sciences |
Approved |
| Intuitional Ethics Committee M.V.Hospital |
Approved |
| Intuitional Ethics Committee MAHAVEIR HOSPITAL |
Approved |
| Intuitional Ethics Committee MDRF |
Approved |
| Intuitional Ethics Committee MGIMS |
Approved |
| Intuitional Ethics Committee Poona Hospital |
Submittted/Under Review |
| Intuitional Ethics Committee Rajamuthai Hospital |
Submittted/Under Review |
| Intuitional Ethics Committee S R Kalla Hospital |
Approved |
| Intuitional Ethics Committee SPANDAN Hospital |
Approved |
| Intuitional Review Board,SJMC |
Approved |
| Sher-I-Kashmir Institute of Medical Science, (EC) |
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 |
| |
Cardiovascular disease secondary prevention therapy. |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 capsules of POLYCAP |
SAME AS INTERVENTION BUT 2 CAPSULES |
| Comparator Agent |
no potassium supplementation |
Not applicable |
| Intervention |
POLYCAP |
ASPIRIN 100mg
ATENOLOL 50MG
RAMIPRIL 5MG
HYDROCHLOROTHIAZIDE 12.5mg
SIMVASTATIN 20mg |
| Intervention |
Potassium citrate |
30 mEq once a day |
|
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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 |
Inclusion Criteria
1. Individuals 40 years and above, with a seated blood pressure > 130/80 mm Hg on two consecutive readings (or BP > 120/80 mm Hg in patients under treatment with 2 or more antihypertensive medication) with one of the following
a. Coronary artery disease; previous myocardial infarction (>7 days post uncomplicated MI), or
b. Ischemic heart disease with significant ECG changes or a positive stress test, or
c. Stable angina or unstable angina and with documented evidence of multi-vessel (angiography or ECG or CT angiography) coronary artery disease, or
d. PTCA or CABG Surgery >30 days before informed consent.
e. Cerebrovascular disease; Previous Ischemic stroke or Transient Ischemic Attacks >30 days before informed consent.
f. High risk diabetes mellitus defined as HbA1C >7.5%, with microalbuminuria or blood pressure >140/90 mm Hg.
g. Peripheral artery disease defined as a current or prior history of: physician diagnosed intermittent claudication or vascular surgery for atherosclerotic disease or an ankle/arm systolic blood pressure ratio > 0.90 in either leg at rest, or angiographic or doppler study demonstrating >70% stenosis in a noncardiac artery.
2. Those who provide informed consent and can comply with medications and follow-up visits.
|
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| ExclusionCriteria |
| Details |
Exclusion criteria
a. Known hypersensitivity or intolerance to any of the study medications or a clear indication for full doses of beta blockers, RAAS blockers (ACEi, ARBs, Renin inhibitors, etc.), diuretics and statins.
b. History of bleeding or having hemorrhagic stroke anytime in the past or a need for continued anticoagulation therapy.
c. Patients having indication for higher doses of aspirin (>200 mg) or needing more than 75mg of clopidogrel daily.
d. Have significant bradycardia (heart rate <50 beats/min) or second- or third-degree heart block without a pacemaker.
e. Planned cardiac surgery or PTCA or any non-cardiac surgery <3months of eligibility assessment.
f. Heart transplant recipient.
g. Renal dysfunction defined as serum creatinine >2 mg/dL and/or serum potassium >5.0 mEq/L.
h. Patients aged >70 years, with mild renal dysfunction defined as serum creatinine >124 µmol/L (1.4 mg/dL) or eGFR <45 ml/min/1.73 m2.
i. Hepatic dysfunction, SGOT or SGPT > 3 x ULN.
j. Taking another experimental drug or within 30days of last dose of the experimental drug.
k. Peptic ulcer disease with bleed, or bleeding diathesis.
l. Bronchial asthma or Chronic Obstructive Pulmonary Disease with asthma.
m. Gout, rheumatoid arthritis or other chronic inflammatory disease requiring long-term medications with NSAIDs.
n. Any history of muscular pain, other pathology of the muscles or past history of muscular pain secondary to taking statins or fibrates.
o. Pregnancy or lactating or women of childbearing potential with inadequate contraception.
p. Inability to attend follow up visits (due to significant disability, inadequate address or contact details, subject from a far off place, psychiatric illness etc.).
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in mean blood pressure |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of lowering mean blood pressure in patients with history of diabetes |
8 weeks |
| Efficacy of potassium to lower mean blood pressure |
8 weeks |
|
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Target Sample Size
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Total Sample Size="500"
Sample Size from India="" |
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Phase of Trial
|
Phase 3/ Phase 4 |
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Date of First Enrollment (India)
|
No Date Specified |
| Date of First Enrollment (Global) |
20/04/2010 |
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Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Salim Yusuf, Prem Pais, Alben Sigamani, Denis Xavier, Rizwan Afzal, Peggy Gao,Koon K. Teo, ” Comparison of Risk Factor Reduction and Tolerability of a Full-Dose Polypill (With Potassium) Versus Low-Dose Polypill (Polycap) in Individuals at High Risk of Cardiovascular Diseases-The Second Indian Polycap Study (TIPS-2) Investigators” Circ Cardiovasc Qual Outcomes,July 2012,5,463-471
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Brief Summary
|
This study is a randomized double blind parallel group 2X2 factorial multi centre trial comparing the safety and efficacy of 2 capsules of polycap (a five drug combination) versus 1 capsule of polycap along with or without potassium.
the primary objective is to establish that a double dose of the low strength polycap can be safely given to individuals with a history of cardiovascular disease and can demonstrate a superior reduction in blood pressure and serum cholesterol.
the study period is 12 weeks with 8 weeks of treatment. all patients will receive an active run in - single capsule first later 2 capsules, for 20 days before randomization.
outcomes are recorded as mean reduction in blood pressure and serum cholesterol.
potassium supplementation will be give openlabel to those randomized to received them. a daily dose of 30mEq is targeted. the safety and tolerance of this supplementation is be studied along with the polycap.
serum cholesterol will be analysed centrally at Super Religare Laboratories Mumbai. Blood pressure will be recorded at site using OMRON devices. |
