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

A STUDY OF PRESCRIBING PATTERN AND EFFECT OF RAMIPRIL, TELMISARTAN AS MONOTHERAPY AND THEIR COMBINATION IN PATIENTS OF TYPE 2 DIABETES MELLITUS WITH HYPERTENSION

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/10/007340

Enrollment

200

Registered

2016-10-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 (10-4

Eligibility

Inclusion 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

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 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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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;3. To monitor the tolerability of ramipril and telmisartan as monotherapy and their combination therapyTimepoint: 6 months;To assess the quality of life (QoL) index in diabetes mellitus patients after drug therapy.Timepoint: 6 months;To compare the efficacy and tolerability of amlodipine as monotherapy on Blood pressure, urinary albumin excretion and creatinine clearance.Timepoint: 6 months;To study the awareness of patients about diabetes mellitusTimepoint: 3 and half years	—

Measure

Time frame

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;3. To monitor the tolerability of ramipril and telmisartan as monotherapy and their combination therapyTimepoint: 6 months;To assess the quality of life (QoL) index in diabetes mellitus patients after drug therapy.Timepoint: 6 months;To compare the efficacy and tolerability of amlodipine as monotherapy on Blood pressure, urinary albumin excretion and creatinine clearance.Timepoint: 6 months;To study the awareness of patients about diabetes mellitusTimepoint: 3 and half years

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Countries

India

Contacts

Public ContactDR H L KAZAL

GURU GOBIND SINGH MEDICAL COLLEGE (BFUHS)

kamleshkohli2014@gmail.com9815499689

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026