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CTRI Number  CTRI/2010/091/001507 [Registered on: 15/10/2010]
Last Modified On: 26/02/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  
A clinical trial to evaluate efficacy and safety of three drug combination ( telmisartan + hydrochlorthiazide + amlodipine ) in the treatment of patients suffering from essential hypertension  
Scientific Title of Study
Modification(s)  
COmparative study evaluating Normalisation of blood pressure with TRiple pill as Outcome against teLmisartan/hydrochlorothiazide in Hypertension (CONTROL-Hypertension Study): A randomized, controlled, double-blind, double-dummy multicenter study to evaluate the efficacy and safety of the combination of Telmisartan/HCTZ/Amlodipine compared to Telmisartan/HCTZ in patients with Essential Hypertension.  
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
CONTROL-H/GMA/2010  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Shilpi Dhawan 
Designation   
Affiliation   
Address  6-3-865, 3rdfloor , Madhupala Towers , Global Medical Affairs
Dr Reddys Laboratories Ltd, Ameerpet
Hyderabad
ANDHRA PRADESH
500016
India 
Phone  040-30783221  
Fax  040-66511536  
Email  shilpid@drreddys.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Shilpi Dhawan 
Designation   
Affiliation   
Address  6-3-865, 3rdfloor , Madhupala Towers , Global Medical Affairs
Dr Reddys Laboratories Ltd, Ameerpet
Hyderabad
ANDHRA PRADESH
500016
India 
Phone  040-30783221  
Fax  040-66511536  
Email  shilpid@drreddys.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr Shilpi Dhawan 
Designation   
Affiliation   
Address  6-3-865, 3rdfloor , Madhupala Towers , Global Medical Affairs
Dr Reddys Laboratories Ltd, Ameerpet
Hyderabad
ANDHRA PRADESH
500016
India 
Phone  040-30783221  
Fax  040-66511536  
Email  shilpid@drreddys.com  
 
Source of Monetary or Material Support
Modification(s)  
Dr Reddys Laboratories Ltd , 8-1027, Road No.:3 Banjara Hills, Hyderabad , INDIA 
 
Primary Sponsor
Modification(s)  
Name  Dr Reddys Laboratories Ltd  
Address  8-2-337, Road No:3 , Banjara Hills , Hyderabad-500034 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
NIL   
 
Countries of Recruitment
Modification(s)  
  India  
Sites of Study
Modification(s)  
No of Sites = 19  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr T.V.Devarajan  Apollo Hospital   First Med,P.H.Road-600010
Chennai
TAMIL NADU 
044-2821111
044-28237470
FIRSTMEDHOAPITAL@APOLLOHOSPITALS.COM 
Dr. Abraham Oomman  Apollo Hospitals  # 645 & 646, TH Road,Tondiarpet,-600081

 
9940754427

aherfchennai@gmail.com 
Dr.Satish Kinagi  Basaveshwar Hospital   Sedam Road,-585105
Gulbarga
KARNATAKA 
9448149091

drsatish_kinagi@hotmail.com 
Dr Siddharth N.Shah  Bhatia Hospital   Bhatia Hospital , ,-40008
Mumbai
MAHARASHTRA 
9819888500

apitxtbk@vsnl.net 
Dr. K A Sambasivam  GKNM Hospital (G.Kuppuswamy Naidu Memorial Hospital)  Dept. of Cardiology,P.B.No. 6327 , Nethaji Road -641037
Coimbatore
TAMIL NADU 
9842221796

drsambasivam@yahoo.com 
Dr.PLN Kapardhi  Global Hospitals  Consultant Cardiologist,Global Hospitals6-1-1070/1 to 4Lakdi-Ka-Pool, -500004
Hyderabad
ANDHRA PRADESH 
9848047521

yamsani.ashwin@gmail.com 
Dr. Jacob Jayan. B  Govt. Medical College  Lecturer in Medicine,Department of General MedicineGovt. Medical CollegeVandanam-688 005

 
9447075720

drjacob.jayan@gmail.com 
Dr Shiva Shankar Polavarapu  Hyderabad Diabetic Centre  near Image Hospital ,Ameerpet-500023
Hyderabad
ANDHRA PRADESH 
040-23752828

hyddiabetes@gmail.com 
Dr B.L.N.Prasad   King George Hospital  Department of Medicine , Unit VI (6), King George Hospital ,Andhra Medical College,-530002
Visakhapatnam
ANDHRA PRADESH 
9848211931

drblnprasad@yahoo.com 
Dr. Satish Rao B  KMC Hospital  Associate professor ,Department of medicine-575001
Bangalore
KARNATAKA 
9845348475

drsatishrao1971@yahoo.com 
Dr K Chockalingam  Kovai Medical Center Kovai Medical Center and Hospital Limited  P.B.No. 3209 , Avanashi Road ,Dept of cardiology-641 014 
Coimbatore
TAMIL NADU 
9842221796
04224323124
kclingam@gmail.com 
Dr Sindhu Joshi   Mahavir Hospital & Research Centre, hyderabad   10-1-1A C Guards , Masab Tank, ,-500004
Hyderabad
ANDHRA PRADESH 
9391099991

dr_sindhu@yahoo.com 
Dr Naveen Chandra Reddy  Mediciti Hospital   5-9-22, Secretrait Road ,-500023
Hyderabad
ANDHRA PRADESH 
9848045814

prodduturnaveen@yahoo.co.in 
Dr Sampath Kumar   Osmania General Hospital  Department of Cardiology , Osmania General Hospital , Afzalgunj ,-500012
Hyderabad
ANDHRA PRADESH 
9848033468

drsampath53@yahoo.com 
Dr Jagdish S.Hiremath  Poona Hospital & Research Centre  27, Sadashiv Pet ,-411030
Pune
MAHARASHTRA 
9890903256

drjagdeshhiremath@gmail.com 
Dr Manju Bhargavi  Radix Diabetes Centre  #29-9-60/1 , GovindarajuluNaidu Street ,Surayaraopet, ,-520002

 
9246474723

drmanjub@gmail.com 
Dr Parth N Patel  St Theresa General Hospital  erragadda,-500019
Hyderabad
ANDHRA PRADESH 
04023814556

parthnp@yahoo.com 
Dr. KP Paulose  SUT Hospital   Chief Physician & Diabetologis,Pattom,-695004

 
9447144434

kpp_sut@ymail.com 
Dr. Ganesh Mathan  Yashoda Hospital  Somajiguda,-500019
Hyderabad
ANDHRA PRADESH 
9866608856

mganesh7@yahoo.co.uk 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
Basaveshwar Hospital ,Institutional Ethics Committee  Approved 
Bhatia Hospital, Institutional Ethics Committee  Approved 
Institutional Ethics Committee , Apollo Hospitals  Approved 
Institutional Ethics Committee, Govt. Medical College  Submittted/Under Review 
Institutional Ethics Committee, Kovai Medical Centre  Approved 
Institutional Ethics Committee, SUT Hospital   Approved 
Institutional Ethics Committee,,Global Hospitals  Submittted/Under Review 
Institutional Ethics CommitteeGKNM Hospital  Approved 
Institutional Ethics CommitteeMediciti Hospital  Approved 
KGH Vizag,Institutional Ethics Committee,  Approved 
KMC Hospital,Institutional Ethics Committee  Approved 
Mahavir Hospital ,Institutional Ethics Committee  Approved 
Osmania Hospital ,Institutional Ethics Committee  Submittted/Under Review 
Poona Hospital ,Institutional Ethics Committee  Submittted/Under Review 
Radix Diabetes Hospital,Institutional Ethics Committee  Approved 
Yashoda Hospital,Institutional Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Essential Hypertension ,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  telmisartan + hydrochlorthiazide  Once daily , 8 weeks 
Intervention  Telmisartan + hydrochlorthiazide +amlodipine  Once daily , 8 weeks 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of both sexes of age ≥ 18 years and ≤ 65 years
2. Patients with uncontrolled hypertension (SBP ≥ 140 mmHg and ≤ 179 mmHg; DBP ≥ 90 mmHg and ≤ 109 mmHg) when treated with full dose of monotherapy (Appendix III) or any of the combinations at the specified doses equipotent to or doses less potent than telmisartan 40 mg + Hydrochlorothiazide 12.5 mg given together (Appendix IV)
3. Non-diabetic patients or Type II diabetic patients with stabilized glycaemic control
4. Patients without CAD or patients with stable angina 
 
ExclusionCriteria 
Details  1. Patients with Stage 2 hypertension with SBP ≥ 180 mmHg and DBP ≥ 110 mmHg 2. Patients with uncontrolled hypertension (SBP ≥ 140 mmHg and DBP ≥ 90 mmHg) when treated with doses of monotherapy, less than that mentioned in Appendix III 3. Patients with uncontrolled hypertension (SBP ≥ 140 mmHg and DBP ≥ 90 mmHg) when treated with any of the combinations at doses more potent than Telmisartan 40 mg + Hydrochlorothiazide 12.5 mg given together (doses higher than those given in appendix IV) 4. Patients with uncontrolled hypertension with combination containing beta blockers or three or more antihypertensive agents 5. Patients with history of unstable angina, myocardial infarction, Stroke, TIA or heart failure 6. Patients with history of moderate or malignant retinopathy, history of hypertensive encephalopathy, arrhythmias, sinus tachycardia or electrolyte imbalance 7. Patients with 2nd or 3rd degree heart block, clinically significant valvular heart disease 8. Patients with uncontrolled diabetes (HbA1c ≥ 9%) 9. Serum creatinine > 1.5 times the upper limit of normal (ULN) 10. Patients with history of hypersensitivity to any of the components of triple pill or sulphonamides 11. Patients with chronic inflammatory conditions, gouty arthritis or other conditions that require the continuous use of NSAIDs 12. Systemic Lupus Erythematosus 13. Acute medical conditions/ surgeries/ alcoholism 14. Medical/ psychiatric conditions likely to hinder trial process 15. Lactating and pregnant women. 16. Women of reproductive age, not practicing reliable contraception. 17. Hepatic dysfunction (AST/ALT/AlkPO4 > 3 times upper limit of normal/ Bilirubin > 1.5 times upper limit of normal (ULN)/ Known hepatic cirrhosis) or existing biliary obstruction  
 
Method of Generating Random Sequence
Modification(s)  
Stratified block randomization 
Method of Concealment
Modification(s)  
Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking
Modification(s)  
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Normalization of blood pressure (SBP 139 & DBP 89 mm Hg in non-diabetics and SBP 129 & DBP 79 mm Hg in diabetics) at the end of 8 weeks treatment period.  Baseline and end of treatment ( 8 weeks) 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
weeks. ? Change from baseline systolic blood pressure at the end of 8 weeks. ? Systolic blood pressure normalization (SBP ≤ 139 mmHg in non-diabetics and SBP ≤ 129 mm Hg in diabetics) or diastolic blood pressure normalization (DBP ≤ 89 mmHg in non-diabetics and DBP ≤ 79 mm Hg in diabetics) at the end of 8 weeks. ? Difference in BP responder rates at the end of 8 weeks as assessed by:  Baseline and end of treatment ( 8 weeks) 
 
Target Sample Size
Modification(s)  
Total Sample Size="512"
Sample Size from India="512" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
Modification(s)  
Phase 3 
Date of First Enrollment (India)
Modification(s)  
15/11/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  15/11/2010 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  
Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NIL 
Brief Summary   This is a phase III randomized , double - blind , double dummy multicenteric trial to evaluate the efficacy and safety of triple drug combination of temisartan / hydrochlorthiazide / amlodipine compared to telmisartan / hydrochlorthiazide in the treatment of essential hypertension  
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