An Eight-week Randomized, 4-arm, Double-blind Study to Compare the Efficacy and Safety of Combinations of Telmisartan 40mg + Amlodipine 5mg Versus Telmisartan 80mg + Amlodipine 5mg Versus Amlodipine 5mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,098
- 试验地点
- 164
- 主要终点
- Number of Patients With Oedema
研究概览
简要总结
The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged at least 18 years at the date of signing the consent form
- •diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study
- •failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
- •able to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's decision)
- •willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation).
排除标准
- •are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
- •known or suspected secondary hypertension
- •mean seated systolic blood pressure (SBP) over 200 mmHg and/or mean seated diastolic blood pressure (DBP) over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHg and/or mean seated DBP over 120 mmHg at the end of the run-in period (Visit 3)
- •any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency)
- •severe renal impairment (e.g. serum creatinine >3.0 mg/dL or >265 mcmol/L, known creatinine clearance <30mL/min or clinical markers of severe renal impairment)
- •bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
- •clinically relevant hyperkalaemia
- •uncorrected volume or sodium depletion.
- •primary aldosteronism.
- •hereditary fructose or lactose intolerance
结局指标
主要结局
Number of Patients With Oedema
时间窗: During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)
Patients from the treated set who experienced at least one case of general oedema.
Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)
时间窗: End of study (8 weeks or last value on treatment)
Change from baseline to the end of study in trough DBP
次要结局
- Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)(End of study (8 weeks or last value on treatment))
- Trough Seated Diastolic Blood Pressure Control(End of study (8 weeks or last value on treatment))
- Trough Seated DBP Response(End of study (8 weeks or last value on treatment))
- Trough Seated SBP Control(End of study (8 weeks or last value on treatment))
- Trough Seated SBP Response(End of study (8 weeks or last value on treatment))
- Trough Seated Blood Pressure (BP) Normality Classes(End of study (8 weeks or last value on treatment))