Clinical trial to assess the efficacy and safety of fixed dose combination of S-Metoprolol and Telmisartan tablets in hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- Responder rate defined as proportion of patients with decrease in diastolic BP by at least 10 mmHg compared to baseline after 12 weeks
研究概览
简要总结
This multicentric, open label, comparative clinical trial is planned to assess efficacy and safety of FDC of S(-) Metoprolol(25 mg) and Telmisartan(20/40 mg) Tablet. Patients stisfing Patient satisfying inclusion and exclusion criteria will receive either Test / Reference drug as per randomization..In Test group patient will receive FDC of S-Metoprolol 25 mg + Telmisartan 20mg and Reference group will receive one tablet of Metoprolol 50mg and Telmisartan 20 mg each. In test group dose will modified in subsequent visit to S-Metoprolol 25mg and Telmisartan 40 mg and in Reference group it will modify upto Metoprolo 50 mg and Olmesartan 40 mg each. (if BP > 140/90). Baseline laboratory investigations will be done. Patients will be evaluated for efficacy and safety variables after 4, 8 and 12 weeks of therapy. Same laboratory investigations will be repeated after 12 weeks of therapy except ECG. The study duration is of 12 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Responder rate defined as proportion of patients with decrease in diastolic BP by at least 10 mmHg compared to baseline after 12 weeks
时间窗: Responder rate defined as proportion of patients with decrease in diastolic BP by at least 10 mmHg compared to baseline after 12 weeks
次要结局
- Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baseline(After 4, 8 and 12 weeks)
- Reduction in mean heart rate compared to baseline(After 4, 8 and 12 weeks)
- Compliance to treatment(After 4, 8 and 12 weeks)
- Subject’s as well as Physicians global assessment about the tolerability of the drug
- Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator(After 4, 8 and 12 weeks)