Health Condition 1: null- Patients with essential hypertension
Conditions
Interventions
Intervention1: S-Metoprolol 25 mg, Telmisartan 20/40 mg: Fixed Dose Combination of S-Metoprolol 25mg and Telmisartan 20/40 mg orally once daily for 12 weeks
Control Intervention1: Metoprolol 50mg, Tel
Sponsors
Emcure Pharmaceuticals Ltd Pune
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients between 18-65 years of age, Patients diagnosed with essential hypertension not controlled on monotherapy or newly diagnosed Stage II hypertensives, Patients willing to give written informed consent and willing to comply with study protocol
Exclusion criteria
Exclusion criteria: Patients previously sensitive to any of the ingredients of the fixed dose combination under study or beta blockers or angiotensin receptor blockers, Patients with history of secondary or malignant hypertension, Patients with evidence of any cardiac arrhythmia on ECG, Patients with known significant respiratory/liver/kidney/neurological diseases / uncontrolled diabetes, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rate defined as proportion of patients with decrease in diastolic BP by at least 10 mmHg compared to baseline after 12 weeksTimepoint: Responder rate defined as proportion of patients with decrease in diastolic BP by at least 10 mmHg compared to baseline after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance to treatmentTimepoint: After 4, 8 and 12 weeks;Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baselineTimepoint: After 4, 8 and 12 weeks;Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigatorTimepoint: After 4, 8 and 12 weeks;Reduction in mean heart rate compared to baselineTimepoint: After 4, 8 and 12 weeks;Subjectâ??s as well as Physicians global assessment about the tolerability of the drug Timepoint: After 12 weeks | — |
Countries
India
Contacts
Public ContactDr Anand V Tendulkar
Outcome results
None listed