A DRUG UTILIZATION STUDY TO SEE THE EFFECTS OF RAMIPRIL, TELMISARTAN AND THEIR COMBINATION IN PATIENTS OF TYPE 2 DIABETES MELLITUS WITH HYPERTENSION

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/10/007340
• Date of registration: 05-10-2016
• Prospective Registration: No
• Primary sponsor: Guru Gobind Singh Medical College
• Public title: A DRUG UTILIZATION STUDY TO SEE THE EFFECTS OF RAMIPRIL, TELMISARTAN AND THEIR COMBINATION IN PATIENTS OF TYPE 2 DIABETES MELLITUS WITH HYPERTENSION
• Scientific title: A STUDY OF PRESCRIBING PATTERN AND EFFECT OF RAMIPRIL, TELMISARTAN AS MONOTHERAPY AND THEIR COMBINATION IN PATIENTS OF TYPE 2 DIABETES MELLITUS WITH HYPERTENSION
• Date of first enrolment: 04-10-2011
• Target sample size: 200
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9939
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 4

Countries of recruitment

India

Contacts

• Name: DR KAMLESH KOHLI
• Affiliation: GURU GOBIND SINGH MEDICAL COLLEGE (BFUHS)

• Name: DR H L KAZAL
• Affiliation: GURU GOBIND SINGH MEDICAL COLLEGE (BFUHS)

Key inclusion & exclusion criteria

Inclusion criteria: Patients with diagnosis of type 2 diabetes mellitus with hypertension in the age group of 30-80 years will be selected for the present study
Exclusion criteria: 1. Diabetic patients with HbA1c >9 %

2. Patients with hepatic disease.

3. Patients with serum creatinine levels of >1.5 mg/dl.

4. Patients with serum potassium >4.6 meq/L.

5. Patients with GFR <25 ml/min.

6. Patients with history of myocardial infarction or PTCA within the preceding 3 months.

7. Patients with severe hypertension i.e. systolic blood pressure >200 mmHg.

8. Patients with history of cerebrovascular accidents.

9. Patients with thyroid disorder.

10. Patients on oral contraceptives.

11. Pregnant and lactating lady.

12. Patients with history of diabetic ketoacidosis.

13. Patients with history of non diabetic renal disease (e.g bilateral renal artery stenosis).

14. Patient with history of adverse effects to ACE inhibitors or ARB blockers or calcium channel blockers (CCBs).



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- TYPE 2 DIABETES MELLITUS WITH HYPERTENSION

Intervention(s)

Intervention1: RAMIPRIL: 2.5-20 MG OD ORAL FOR 24 WEEKS

Intervention2: TELMISARTAN: 40-80 MG OD ORAL FOR 24 WEEKS

Intervention3: RAMIPRIL PLUS TELMISARTAN: RAMIPRIL (2.5-10 MG)PLUS TELMISARTAN (10-40 MG)OD ORAL FOR 24 WEEKS
Control Intervention1: AMLODIPINE: 2.5-10 MG OD ORAL FOR 24 WEEKS

Primary Outcome(s)

To see the effects of study drugs on Blood pressure, Pusle rate, urinary albumin excretion and creatinine clearanceTimepoint: Study period is 4 (four) years

Secondary Outcome(s)

To assess the quality of life (QoL) index in diabetes mellitus patients after drug therapy.Timepoint: 6 months

To study the awareness of patients about diabetes mellitusTimepoint: 3 and half years

3. To monitor the tolerability of ramipril and telmisartan as monotherapy and their combination therapyTimepoint: 6 months

1. To study the drug prescribing patterns in patients of diabetes mellitus in Department of Medicine, Guru Gobind Singh Hospital- FaridkotTimepoint: 3 and half years

To compare the efficacy and tolerability of amlodipine as monotherapy on Blood pressure, urinary albumin excretion and creatinine clearance.Timepoint: 6 months

Secondary ID(s)

BFUHS/EX/PHD/E6/11-7478

Source(s) of Monetary Support

I (Dr RAJ KUMAR) am depositing annual fee as PhD Candidate to the BFUHS and GGS Medical college, Faridkot for use of laboratory and other services. I am not getting Monetary help from any body. GGS Medical College and Hospital helping me to use laboratory and other hospital services only.

Ethics review

Status: Approved
Approval date: 05/08/2016
Contact:

Institutional Ethics Committee situated at Guru Gobind Singh Medical College, University Centre of Excellence In Research, Academic Block, Baba Farid University of Health Sciences, Sadiq Road Faridkot,151203, Punjab- India.

Results

• Date Completed: 30/07/2015