| CTRI Number |
CTRI/2011/06/001820 [Registered on: 21/06/2011] Trial Registered Prospectively |
| Last Modified On: |
02/11/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Trial of S-Amlodipine , Olmesartan and Hydrochlorothiazide combination tablet in the treatment of Hypertension" |
|
Scientific Title of Study
|
Clinical Study to assess the efficacy and safety of fixed dose combination of S-Amlodipine besilate, Olmesartan medoxomil and Hydrochlorothiazide tablets in hypertension |
| Trial Acronym |
SAOH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EPL/2010/SAOH/01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anand V Tendulkar |
| Designation |
Manager - Medical |
| Affiliation |
|
| Address |
Emcure Pharmaceuticals Ltd,
Rajiv Gandhi IT Park Phase I, MIDC, Hinjwadi
Pune
MAHARASHTRA
411057
India
Pune
MAHARASHTRA
411057
India |
| Phone |
020-39821000 |
| Fax |
020-39821019 |
| Email |
Anand.Tendulkar@emcure.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand V Tendulkar |
| Designation |
Manager - Medical |
| Affiliation |
|
| Address |
Emcure Pharmaceuticals Ltd,
Rajiv Gandhi IT Park Phase I, MIDC, Hinjwadi
Pune
MAHARASHTRA
411057
India
Pune
MAHARASHTRA
411057
India |
| Phone |
020-39821000 |
| Fax |
020-39821019 |
| Email |
Anand.Tendulkar@emcure.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand V Tendulkar |
| Designation |
Manager - Medical |
| Affiliation |
|
| Address |
Emcure Pharmaceuticals Ltd,
Rajiv Gandhi IT Park Phase I, MIDC, Hinjwadi
Pune
MAHARASHTRA
411057
India
Pune
MAHARASHTRA
411057
India |
| Phone |
020-39821000 |
| Fax |
020-39821019 |
| Email |
Anand.Tendulkar@emcure.co.in |
|
|
Source of Monetary or Material Support
|
| Emcure Pharmaceuticals Ltd, Pune. |
|
|
Primary Sponsor
|
| Name |
Emcure Pharmaceuticals Ltd Pune |
| Address |
Emcure Pharmaceuticals Ltd,
Rajiv Gandhi IT Park Phase I, MIDC, Hinjwadi
Pune
MAHARASHTRA
411057
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 19 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhir Bhatnagar MDMed FRCGPUK |
Abhinav Multispeciality Hospital |
Kamal Chowk, Nagpur-440017
Nagpur
MAHARASHTRA |
0712-2641715
drsudhirbhatnagar@gmail.com |
| Dr S Balamurugan MB DTCD DNB |
Chest Research Centre |
# 2,First Cross, Janki Nagar Extension, Valasaravakkam,
Chennai-600087
Chennai
TAMIL NADU |
044-24865796
dr.s.bala@gmail.com |
| Dr Ajay B Dande MDMed |
Dande Diabetes and Heart care Centre, Maternity Home |
Bhagwant, 49, Maya Nagar, N-2, Behind Hotel Deepali Exceutive, CIDCO, Aurangabad
Aurangabad
MAHARASHTRA |
0240-2483456
drdande@yahoo.com |
| Dr Suresh Gaikwad MBBS MDMed |
Dr Gaikwads Critical Care Centre |
31, Reshimbag, Sakkardara Square, Umrer Road,
Nagpur-440009
Nagpur
MAHARASHTRA |
0712-2740741
gaikwadhospital@ymail.com |
| Dr Ashish Badadare MDMed |
Giridhar Clinic |
Shree Oshiya Corner Building,
In front of Sukhsagar Telephone Exchange,
Sukhsagar Nagar, Pune-411016
Pune
MAHARASHTRA |
020-26961911
ashishpb2008@gmail.com |
| Dr Rajeev C Naik MDMed |
Ketki Hospital |
Plot No. 477, N-3, CIDCO
In front of Chate House
Near Kamgar Chowk, Aurangabad-431003
Aurangabad
MAHARASHTRA |
0240-2482902
rajivcnaik@indiatimes.com |
| Dr Ashish Magdum MDMed DMCardio |
Kranti Cardiac Centre |
Behind Kranti Clinic, Stand Road,
Sangli-416416
Sangli
MAHARASHTRA |
0233-25307555
ashishmagdum@hotmail.com |
| Dr Biswakesh Majumdar |
Medicine Research & Diagnostic Pvt. Ltd. |
68, Chowanghee Road, Kolkata-700020
Kolkata
WEST BENGAL |
033-22811138
dr_biswakes@yahoo.co.in |
| Dr Tulsi Das Bhattacharjee |
Nightingale Hospital |
11, Shakesphere Sarani, Kolkata - 700071
Kolkata
WEST BENGAL |
033-22825377
dr.tulsidas.b@gmail.com |
| Dr D N Hambire MDMed |
Noble Hospital Pvt. Ltd. |
153, Magarpatta City Road,
Hadapsar, Pune-400013
Pune
MAHARASHTRA |
9823979775
poonamzodage@gmail.com |
| Dr Rajesh P Enadle MDMed |
Prabhavati Multispeciality Hospital & Research Centre |
Ambajogai Road,
Latur-413512
Latur
MAHARASHTRA |
02382-227111
enadle@gmail.com |
| Dr J Sangumani MD D Diab |
Radianz Clinical Services |
662, K K Nagar, Madurai - 625020
Madurai
TAMIL NADU |
0452-2580991
jeyaraman.sangumani@gmail.com |
| Dr S SivaRamasubramanian MDMed |
Radianz Clinical Services |
662, K K Nagar, Madurai - 625020
Madurai
TAMIL NADU |
0452-2580991
drsivaramsubramanian.radianz@gmail.com |
| Dr Praveen K Jain |
Sanjeevan Hospital |
6th Lane, Laxmi Road,
A/P Jaysingapur, Dist - Kolhapur
Pin - 416101
Kolhapur
MAHARASHTRA |
9422046659
pravindrj@gmail.com |
| Dr Indraneel Basu MDMed |
Sanjeevani Clinic |
B 15/56, Sonarpura,
Opposite Gauria Math,
Varanai
Varanasi
UTTAR PRADESH |
0542-3251542
dribasumd@yahoo.co.in |
| Dr Shantanu Sengupta MD DNB FASE FCCP |
Sengupta Hospital & Research Institute |
Ravinagar square, Nagpur
Nagpur
MAHARASHTRA |
9823570925
senguptasp@gmail.com |
| Dr Mahesh Padsalge MDMed |
Shivam Clinic & Research Centre |
Shop No 23, Ambika Shopping Centre,Sector 8 Nerul, Navi Mumbai-400706
Mumbai
MAHARASHTRA |
022-27719497
drmaheshpadsalge@gmail.com |
| Dr Rajesh R Deshmane MBBS FCPSMed D Diabetology |
Shree Mahalaxmi Diabetis Care Centre |
OS-14, Akshar Plaza, Opposite Sasane Ground, Main Road, Tarabai Park, Kolhapur-416001
Kolhapur
MAHARASHTRA |
0231-2662345
smdcc_kolhapur@yahoo.co.in |
| Dr Sanjay R Mane |
Spandan Clinic, |
Bazarpeth, Ahilya Nagar,
Kupwad, Sangli-416425
Maharashtra
Sangli
MAHARASHTRA |
9325071233
dockumar12@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee Dande Diabetes and Heart Care Centre, Maternity Home |
Approved |
| Ethics Committee Nightingale Hospital |
Approved |
| Ethics Committee Radianz Clinical Services |
Approved |
| Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 |
Approved |
| Institutional Ethics Committee Noble Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
hypertension , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fixed Dose combination of Amlodipine 5mg and Hydrochlorothiazide 12.5mg Tablet & Olmesartan 40 mg tablet |
Low Dose - Fixed Dose combination of Amlodipine 5mg and Hydrochlorothiazide 12.5mg one Tablet once daily & Olmesartan 40 mg one tablet once daily for 12 weeks.If required (BP 140/90 mm Hg )dose may be increased to Fixed Dose combination of Amlodipine 5mg and Hydrochlorothiazide 12.5mg Two Tablet once daily in addition to Olmesartan 40 mg one tablet once daily in subsequent visit upto 12 weeks of therapy. |
| Intervention |
Fixed Dose Combination of S-Amlodipine2.5/5 mg,Olmesartan 40 mg and Hydrochlorothiazide 12.5/25 mg tablet |
Low Dose - Fixed Dose Combination of S-Amlodipine 2.5mg,Olmesartan 40 mg and Hydrochlorothiazide 12.5mg tablet once daily for 12 weeks. If required dose may be increased upto Fixed dose combination of S-Amlodipine 5mg, Hydrocholorothiazide 25 mg and Olmesartan 40 mg tablet once daily upto 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male or female patients between 18-65 years of age, Subjects diagnosed with essential hypertension not controlled on monotherapy or two drug therapy or newly diagnosed Stage II hypertensives, Subject willing to give written informed consent and willing to comply with study protocol
|
|
| ExclusionCriteria |
| Details |
Subjects previously sensitive to any of the ingredients of the fixed dose combination under study or calcium channel blockers or angiotensin receptor blockers or thiazide diuretic, Subjects with history of secondary or malignant hypertension, Patients with known significant respiratory/liver/kidney/neurological diseases / uncontrolled diabetes, Patients with evidence of any cardiac arrhythmia on ECG, Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception, Patients who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug, Patients with known alcohol or drug abuse, 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
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Responder rate defined as proportion of patients with decrease in diastolic BP by at least 10 mmHg compared to baseline at 12 weeks of therapy |
Responder rate defined as proportion of patients with decrease in diastolic BP by at least 10 mmHg compared to baseline at 12 weeks of therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baseline |
After 4, 8 and 12 weeks of thearapy |
| Mean reduction in heart rate compared to baseline |
After 4, 8 and 12 weeks of therapy |
| Compliance to therapy |
After 4, 8 and 12 weeks of therapy |
Subject’s as well as Physician’s global assessment about the tolerability of the drug
|
After 12 weeks of therapy |
| Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator |
After 4, 8 and 12 weeks of therapy |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2011 |
| 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="1"
Months="0"
Days="0" |
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
|
This multicentric, open label, Randomized, Comparative clinical trial is planned to assess efficacy and safety of FDC of S - Amlodipine besilate (2.5/5 mg), Hydrochlorothiazide 12.5/25 mg and Olmesartan 40 mg Tablet. Patient satisfying inclusion and exclusion criteria will receive either test or Reference drug as per Randomization.In test group at screening visit patient will start with FDC of S-Amlodipine 2.5 mg, Hydrocholorothiazide 12.5 mg and Olmesartan 40mg one tablet once daily for first 4 weeks and in subsequent visit if BP >140/90 mm of Hg then dose of FDC will increased upto S-Amlodipine 5mg + Olmesartan 40 mg + Hydrochlorothiazide 25 mg once daily upto 12 weeks. If dose doesnot modified same dose will continue.In Reference group initially patient will start with FDC of Amlodipine 25mg with Hydrochlorothiazide 12.5 mg one tablet once daily with Olmesartan 40 mg one tablet once daily. In subsequent visit if BP>140/90 mm of Hg then this dose will increase upto FDC of Amlodipine 25mg + Hydrocholorthiazide 12.5 mg two tablets once daily along with Olmesartan 40 mg one tablet once daily.Baseline laboratory investigations will be done. Patients will be evaluated for efficacy and safety variables after 4, 8 and 12 weeks of therapy. Same laboratory investigations will be repeated after 12 weeks of therapy except ECG.The study duration is of 12 weeks |