A Multicentre, Comparative, Controlled, Open Label, Randomized, Parallel Group, Phase III Study to Evaluate the Safety and Efficacy of Fixed Dose Combination Containing Rosuvastatin Calcium with Amlodipine Besylate versus Monotherapy for Stage 1 and Stage 2 Hypertension in Dyslipidemic Patients.
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 330
- 试验地点
- 6
- 主要终点
- •The percentage of reduction in systolic and/or diastolic blood pressure from baseline with fixed dose combination of rosuvastatin calcium (5/10/20 mg) with amlodipine besylate (2.5/5/10 mg) vs amlodipine besylate 5 mg monotherapy
研究概览
简要总结
This is a multicentre, randomized, parallel-group, open label study to compare the safety and efficacy of FDC containing rosuvastatin calcium and amlodipine besylate on stage 1 and stage 2 hypertension with dyslipidemic patients with that of monotherapy. There are 11 treatment arms planned for this study, 9 fixed dose combination arms of rosuvastatin calcium (5/10/20 mg/day) + amlodipine besylate (2.5/5/10 mg/day) and two monotherapy arms of rosuvastatin calcium (10 mg/day) and amlodipine besylate (5 mg/day). The study is planned to enroll a total of 330 patients; 30 patients in each arm.Patients will be stratified based on the SBP/DBP and LDL-C levels and randomized within each stratum with equal proportion to any of the treatment arms within the stratum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients willing to give informed consent 2.Male and female patients with stage 1 (SBP ≥140 mmHg / DBP ≥90 mm Hg- SBP 159mmHg / DBP 99 mm Hg) and stage 2 hypertension(SBP ≥160 mmHg / DBP ≥90 mm Hg- SBP 180mmHg / DBP ≥110 mm Hg 3.Border line high (LDL value between 130-159) and high dyslipidemic (LDL values between 160-189) 4.Subjects aged 18 years and above 5.Patients with hypertension who are on stable medication for at least 3 months, but their blood pressure is not adequately controlled 6.Hypertensive patients who are not taking treatment or taking irregular treatment, and hypertensive patients who are not responding to the treatment; but not on amlodipine besylate 7.Patients who are willing to comply with all study requirements 8.Females of childbearing potential should have a negative pregnancy test at the pre study visit and agree to use contraception during the study.
排除标准
- •1.Patients who are unlikely to comply with protocol requirements (e.g., non-cooperative behavior, inability to attend the required by the protocol visits).
- •2.Patients who are currently participating or had participated in other interventional study for last 3 months prior to their enrolment.
- •3.Known CVD, triglycerides 500 mg/dL, renal disease (serum creatinine levels 1.6 mg/dL), hypothyroidism, liver disease (ALT and/or AST levels 3-fold upper limit of normal in more than 2 consecutive measurements), 4.Alcohol consumption 3 drinks/day for men and 2 drinks/day for women, and current or previous gout.
- •5.Patients with HbA1c ≥ 9% 6.Patients who are positive for HIV test.
- •7.Patients currently taking lipid-lowering drugs other than statins.
- •8.Patients with abnormal Creatine Kinase (CK) level ( 2.5 times the upper normal limit).
结局指标
主要结局
•The percentage of reduction in systolic and/or diastolic blood pressure from baseline with fixed dose combination of rosuvastatin calcium (5/10/20 mg) with amlodipine besylate (2.5/5/10 mg) vs amlodipine besylate 5 mg monotherapy
时间窗: 12 weeks (84 days) of therapy
•The percentage of reduction in LDL-C levels from baseline with fixed dose combination of rosuvastatin calcium (5/10/20 mg) with amlodipine besylate (2.5/5/10 mg) vs rosuvastatin calcium 10 mg monotherapy
时间窗: 12 weeks (84 days) of therapy
次要结局
- •Incidence of adverse events (AEs) and serious adverse events (SAEs) during the study period(•Clinically significant changes in vital signs.)
- •The percentage of patients treated with FDC of rosuvastatin calcium (5/10/20 mg) with amlodipine besylate (2.5/5/10 mg) vs monotherapy of amlodipine besylate 5mg, achieving recommended blood pressure levels(•The percentage of change in HDL-C, TC and fasting TG levels)