Health Condition 1: null- Diabetic Hypertension
Conditions
Interventions
Intervention1: Telmisartan 40mg manufactured by Troikaa Pharmaceuticals: One tablet once daily for 2 weeks
Intervention2: Escalate to Telmisartan 80 mg if needed: One tablet once daily for 2 weeks
In
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18-65 years. 2. Diabetic with FPG >= 126 mg/dl (7.0 mmol/l) 3. Patients with Stage I hypertension (JNC 7 guidelines) 4. Newly diagnosed treatment naïve/ currently untreated hypertension or patients unable to tolerate current antihypertensive therapy.
Exclusion criteria
Exclusion criteria: 1. Age below 18 years and above 65 years 2. Stage 2 hypertension (JNC 7 guidelines) 3. Secondary hypertension 4. Any acute medical condition 5. Uncontrolled diabetes mellitus 6. Baseline laboratory values outside the clinically acceptable limits 7. Pregnant women and lactating mothers 8. Females of child bearing age not practicing contraception or not willing to use barrier contraceptive 9. Patients or relatives unwilling to give written informed consent 10. Participation in a clinical study involving an investigational product within past 30 days. 11. Known hypersensitivity to telmisartan/ ARB or any component of the formulations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SBP & DBP as compared to baselineTimepoint: At the end of week 2,4 & 8;Change in SBP & DBP as compared to baselineTimepoint: At the end of week 2,4 & 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in UAER as compared to baselineTimepoint: At 8 weeks (end of the study);Global efficacy by patients and investigatorTimepoint: At 8 weeks (end of the study);Percentage of patients with blood pressure controlledTimepoint: At the end of week 4 | — |
Countries
India
Contacts
Public ContactDr Vijaya Jaiswal
Outcome results
None listed