Clinical Study to assess the efficacy and safety of fixed dose combination of S-Metoprolol, Atorvastatin and Ramipril tablets in hypertension coexisting with hyperlipidemia
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
- 17
- 主要终点
- Proportation of patients with decrease in diastolic blood pressure by atleast 10 mm hg compared to baseline at the end of study.
研究概览
简要总结
This multicentric, open label, non-comparative clinical trial is planned to assess efficacy and safety of FDC of S -Metoprolol , Atorvastatin and Ramipril Tablet. in the treatment of hypertension coexisting with hyperlipidemia.Patient satisfying inclusion and exclusion criteria will receive Fixed Dose Combination of S (-) Metoprolo Succinate 50 mg + Atorvastatin 10 mg + Ramipril 5 mg tablet orally once a day. Dose will modified in subsequent visit to S (-) Metoprolo Succinate 25 mg + Atorvastatin 10 mg + Ramipril 5 mg tablet (if BP < 110/75). 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
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects diagnosed with essential hypertension not controlled on monotherapy or newly diagnosed Stage II hypertensives, Patients with serum LDL-C level more than or equal to 130 mg/dL and triglyceride Level lesser than or equal to 350 mg/dL,Subject willing to give written informed consent and willing to comply with study protocol.
排除标准
- •Subjects previously sensitive to any of the ingredients of the fixed dose combination under study or beta blockers or statins or angiotensin receptor blockers, Subjects with history of secondary or malignant hypertension, Patients with significant known respiratory/liver/kidney/neurological diseases / uncontrolled diabetes, Patients with any evidence of cardiac arrhythmia on ECG, Known history of myopathy or rhabdomyolysis with statins, 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 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
Proportation of patients with decrease in diastolic blood pressure by atleast 10 mm hg compared to baseline at the end of study.
时间窗: After 12 weeks
次要结局
- Mean change in LDL-C Levels as compared to Baseline(After 12 weeks)
- Mean reduction in Systolic and Diastolic Blood pressure compared to baseline(After 4, 8 and 12 weeks)
- Percent of subjects experiencing any drug related adverse events as evaluated and recorded by the investigator(After 4, 8 and 12 weeks)
- Mean reduction in heart rate compared to baseline(After 4, 8 and 12 weeks)
- Mean change in total cholesterol, HDL and triglycerides as compared to baseline(After 12 weeks)
- Compliance of Therapy(After 4, 8 and 12 weeks)
- Subjects as well as Physicians global assessment about tolerability of drugs(After 12 weeks)