NCT00624052已完成3 期
An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 838
- 试验地点
- 92
- 主要终点
- Trough Seated Diastolic Blood Pressure (DBP) Control
研究概览
简要总结
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months.
An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.
The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP < 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).
研究设计
- 研究类型
- Interventional
- 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
- •- diagnosis of essential hypertension
排除标准
- •pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
- •development of any condition in the preceding trial that could be worsened by telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10).
- •discontinuation from the preceding trial.
- •known or suspected secondary hypertension.
- •mean seated systolic blood pressure (SBP) >= 180 mmHg and/or mean seated diastolic blood pressure (DBP) >= 120 mmHg at any visit.
- •any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
- •clinically relevant hyperkalaemia.
- •uncorrected volume or sodium depletion.
- •primary aldosteronism.
- •hereditary fructose or lactose intolerance.
- •symptomatic congestive heart failure.
- •patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
- •any new drug or alcohol dependency since signing consent of the preceding trial.
- •concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial.
- •hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
- •known allergic hypersensitivity to any component of the formulations under investigation. [Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine calcium channel blockers (CCBs).] non-compliance with study medication (defined as <80% or >120%) during the preceding trial.
- •administration of ARBs or dihydropyridine CCBs (apart from trial medication). any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.
结局指标
主要结局
Trough Seated Diastolic Blood Pressure (DBP) Control
时间窗: End of study (34 weeks or last value on treatment)
The number of patients who reached the target DBP of \<90mmHg
次要结局
- Trough Seated Systolic Blood Pressure (SBP) Control(End of study (34 weeks or last value on treatment))
- Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure(Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment)
- Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052(Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment))
- Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure(Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment)
- Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052(Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment))
- Trough Seated DBP Response(End of study (34 weeks or last value on treatment))
- Trough Seated SBP Response(End of study (34 weeks or last value on treatment))
- Trough BP Normality Classes(End of study (34 weeks or last value on treatment))
- Time to First Additional Antihypertensive(up to 34 weeks)
- Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control(up to 34 weeks)
- Additional Reduction in DBP by Use of Additional Antihypertensive Therapy(up to 34 weeks)
- Additional Reduction in SBP by Use of Additional Antihypertensive Therapy(up to 34 weeks)
- Trough DBP Control Pre- and Post- Uptitration(up to 34 weeks)
研究者
研究点 (92)
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