| CTRI Number |
CTRI/2008/091/000190 [Registered on: 04/02/2009] |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components |
Scientific Title of Study
Modification(s)
|
A Five-Arm, Randomised, Open Label, Multi-Centre, Prospective Study to Compare the Efficacy, Safety and Tolerability of Metoprolol XL Plus Amlodipine Combination (Selomax TM) With Metoprolol XL and Amlodipine as Individual Components in Management of Hypertension in Indian Patients. (MARS) |
| Trial Acronym |
MARS |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT00819104 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Denis Xavier |
| Designation |
|
| Affiliation |
|
| Address |
Division of Clinical Trials
St Johns Research Institute, Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08025523416 |
| Fax |
08025633382 |
| Email |
drdenisxavier@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Denis Xavier |
| Designation |
|
| Affiliation |
|
| Address |
Division of Clinical Trials
St Johns Research Institute, Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08025523416 |
| Fax |
08025633382 |
| Email |
drdenisxavier@hotmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Padmini Devi |
| Designation |
|
| Affiliation |
|
| Address |
Department of Pharmacology, St.Johns Medical College
Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
08022065045 |
| Fax |
08025633382 |
| Email |
p_nidhin@hotmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
AstraZeneca |
| Address |
AstraZeneca Pharma India Ltd.,
PB No.2483
Off Bellary Road, Hebbal
Bangalore 560024 (INDIA) |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashokan Nambiar |
Baby Memorial Hospital |
Indira Gandhi Road,-673 004
Kozhikode
KERALA |
0495 - 2723222
0495-2723484
info@babymhospital.org, binduarekkal@yahoo.com |
| Dr Rajeev Gupta |
Fortis Escorts Hospital |
Jawaharlal Nehru Marg,Malviya Nagar-302017
Jaipur
RAJASTHAN |
0141-2547000
0141-4008151
rajeevg@satyam.net.in, rajeevg@sify.com, research_fortis@hotmail.com |
| Dr. Ketan Mehta |
Health and Harmony |
#2 Dattani Chambers,S V Road, Malad-400064
Mumbai
MAHARASHTRA |
022-28827500
022-28837500
healthharmony@indiatimes.com, ketanmehta@gmail.com |
| Dr Kamal Sharma |
Lifecare Institute Of Medical Sciences & Research |
Sardar Patel Colony Corner,Navrangpura-380014
Ahmadabad
GUJARAT |
09426020154
07926405210
kamalsharma1975@rediffmail.com |
| Dr Sindhu Joshi |
Mahavir Jain Hospital |
Bhagavan Mahavir Jain Marg, AC Guards-500004
Hyderabad
ANDHRA PRADESH |
040-23320447
040-23320447
madhurisamirmahajan@yahoo.com, dr_sindhujoshi@yahoo.com |
| Dr. Vinod Sharma |
National Heart Institute |
49-50, Community center,East of kailash-110065
New Delhi
DELHI |
011-26428372
011-26428372/ 26225733
drvs1994@rediffmail.com, mail2ahmed@rediffmail.com |
| Dr Jagdish Hiremath |
Poona Hospital & Reserch Centre |
#27,Sadashiv peth-411030
Pune
MAHARASHTRA |
020-24331706
020-24321991
jagdish_hiremath@vsnl.net, drmanisham@gmail.com, phrc@gamil.com |
| Dr Girija Singh |
St Johns Medical Hospital |
Koramangala,-560 034
Bangalore
KARNATAKA |
09844707528
drsoumya239@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Baby Memorial Hospital |
Approved |
| Fortis Escorts Hospital |
Approved |
| IERB |
Approved |
| Independant Ethics Comittee |
Approved |
| Independant Ethics Comittee |
Approved |
| Mahavir Hospital |
Approved |
| Peerless Hospital |
Submittted/Under Review |
| Poona Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Hypertension, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Amlodipine |
5mg OD, 8 weeks |
| Intervention |
Drug: Metoprolol XL 50mg + Amlodipine 5mg |
Once Daily, 8 weeks |
| Comparator Agent |
Metoprolol XL |
25mg OD, 8 weeks |
| Comparator Agent |
Metoprolol XL |
50mg OD, 8 weeks |
| Intervention |
Metoprolol XL 25 mg + Amlodipine 2.5mg |
Once Daily, 8 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Patients of hypertension (primary) , as judged by 2 BP measurements before randomisation
Those who have given their written consent for the study |
|
| ExclusionCriteria |
| Details |
Patients of other forms of hypertension (other than primary)
Those who have consistently BP > /=180/120mmHg
Patients with a prior history of chest pain, heart attacks, conduction defects and strokes.
Patients of diabetes requiring insulin,asthma and kidney diseases.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in BP with Selomax? 50/5 at the end of the randomisation treatment period. |
Time Frame: 8 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period |
Time Frame: 8 weeks |
| Change in the heart rate,Number of responders & control rates |
Time Frame: 8 weeks |
| Incidence of adverse events (serious and non-serious) in each arm.Change in hemogram, serum chemistry (Liver function tests (LFT), Renal function tests (RFT), plasma lipids, Blood Glucose, HbA1c), and Ur.albumin |
8 weeks, Safety issue |
|
Target Sample Size
Modification(s)
|
Total Sample Size="402"
Sample Size from India="402"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="402" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
07/11/2008 |
| Date of Study Completion (India) |
31/07/2009 |
| Date of First Enrollment (Global) |
17/11/2008 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Effect of fi xed dose combinations of metoprolol and amlodipine in
essential hypertension: MARS –A randomized controlled trial
Devi, P., Xavier, D., Sigamani, A., Pandey, S., Thomas, T., Murthy, S., … Pais, P. (2011). Effect of fixed dose combinations of metoprolol and amlodipine in essential hypertension: MARS – A randomized controlled trial. Blood Pressure, 20(sup2), 5–12. https://doi.org/10.3109/08037051.2011.617040
https://www.tandfonline.com/doi/full/10.3109/08037051.2011.617040 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a randomised, open-label; parallel group, multicentric study comparing the efficacy and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female patients of essential hypertension aged between 18-80 years will be studied. The patients should not have a history of prior cardiovascular disease. The outcomes are BP lowering and the tolerability of the fixed dose combinations compared to the individual comparators. |