CTRI/2009/091/000580已完成2 期
A Prospective, Randomized, Multi-national, Multi-center, Double-Blind, Placebo-Controlled, Six-arm, Parallel-group, Phase II (Factorial Design) Study to Evaluate the Safety and Efficacy of Two Fixed Dose Combinations of Irbesartan / Amlodipine (150 mg/ 5 mg and 300 mg/ 5 mg) and Monotherapy (Amlodipine 5 mg, Irbesartan 150 mg and 300 mg) after Eight Weeks of Treatment in Subjects with Uncomplicated Mild to Moderate Essential Hypertension.
SanofiSynthelabo India Limited7 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2009年4月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 7
- 主要终点
- Difference in mean change from baseline at the end of 8 weeks in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo
研究概览
简要总结
This is a prospective randomized, multi-national, multi-center, double-blind, double dummy, placebo-controlled, six-arm, parallel-group, phase II, factorial design study. This study will be conducted in Korea, Taiwan, India and Philippines. The primary endpoint will be the difference in mean change from baseline at the end of 8 weeks in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo. The Secondary endpoint: 1) Difference in mean change from baseline in SeSBP at end of 8 weeks between each FDC, its individual constituents administered as monotherapy and placebo. 2) Difference in mean change from baseline in SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo. 3) Safety endpoints: The safety and tolerability of the FDCs, monotherapies and placebo will be assessed by the Clinical AEs, including laboratory abnormalities. 72 patients will be enrolled from India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with uncomplicated mild to moderate essential hypertension (as per European Society of Cardiology Classification of Hypertension) Treatment naïve subjects (newly diagnosed subjects or subjects currently only on lifestyle modification) with mean SeDBP of 95 to 109 mmHg at both screening and randomization visit (mean of 3 recordings at intervals of 1 minute) Or Uncontrolled on any anti-hypertensive monotherapy and with mean SeDBP of 90 to 109 mmHg at screening and mean SeDBP of 95 to 109 mmHg at the randomization visit (mean of 3 recordings at intervals of 1 minute).
- •Signed written informed consent obtained prior to inclusion in the study.
- •Subjects willing to adhere to protocol and study requirements during the entire study duration.
- •Subjects having no abnormalities in general physical examination.
排除标准
- •a.Subjects who are incapable of giving informed consent for the study.b.Subjects with SeDBP≥110mmHg and / or SeSBP≥180 mmHg measured at Doctor's office during screening or randomization visitc.Subjects having a difference of > 8 mmHg between any 2 of the 3 SeDBP measurements either at screening or at randomization.d.Subjects who are on any anti-hypertensive therapy and unable to discontinue the anti-hypertensive therapy safely for a period of at least 2 weeks as required by the protocol.e.Subjects who cannot be discontinued on medications prohibited by the protocol.f.Subjects on combination therapies for treatment of hypertension.g.Subjects with known documented secondary hypertension including (but not limited to) hypertension secondary to coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing?s disease, pheochromocytoma, polycystic kidney disease, etc.
- •h.Subjects with known diabetes (Type 1 or Type 2).i.Subjects with known documented complications of hypertension including (but not limited to):1.Cardiovascular disease: Ischemic heart disease (angina, myocardial infarction), heart failure, peripheral vascular disease.2.Cerebrovascular disease: Stroke, cerebral hemorrhage.3.Ophthalmic: Retinal hemorrhage, impaired vision, retinal microaneurysms.4.Subjects with known severe renal impairment (creatinine clearance < 30 ml/min) calculated using the Cockcroft-Gault equation.k.Subjects with hyperkalemia (>5.1mmol/L) and/or hyponatremia (<133mmol/L).l.Subjects with known severe hepatic impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal or history of hepatic encephalopathy, esophageal varices, or portocaval shunt.m.Subjects with clinically significant abnormalities on ECGn.Subjects with any other clinical condition which, in the opinion of the Investigator, might interfere with administration of Irbesartan or Amlodipine and evaluation of the study objectives.o.Subjects with known history of allergy considered due to any of the study drugs or their components, including excipients (lactose) and preservatives.p.Subjects with known history of substance abuse (drug or alcohol dependency, alcohol, if not stopped, <20gms per day will be allowed during the study period).q.Subjects known positive for HIV 1 or 2 virus.r.Subjects with known or suspected impairment of the immune function, and/or receiving immunosuppressive therapy, or having received immunosuppressive therapy within 30 days prior to study entry.s.Subjects who have received any other investigational drug within 30 days before inclusion.t.Pregnant (demonstrating a positive serum (β-HCG) pregnancy test at screening visit) or lactating female subjects.u.Subjects and partners unwilling to employ adequate contraception during the course of the study.
- •Adequate contraception methods include condom, spongy, loop in the uterus, and so on.
- •Contraceptive drugs can not be used.
结局指标
主要结局
Difference in mean change from baseline at the end of 8 weeks in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo
时间窗: 8 weeks
次要结局
- Difference in mean change from baseline in SeSBP at end of 8 weeks between each FDC, its individual constituents administered as monotherapy and placebo(8 weeks)
- Difference in mean change from baseline in SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo(4 weeks)
- The safety and tolerability of the FDCs, monotherapies and placebo will be assessed by the Clinical AEs, including laboratory abnormalities(During the treatment duration)
研究者
研究点 (7)
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