NCT00614380已完成3 期
An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg 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
- 976
- 试验地点
- 154
- 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 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.
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
- •patients aged at least 18 years
- •diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.
- •failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.
排除标准
- •pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study
- •development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg
- •discontinuation from the preceding trial because of any adverse event or any other reason
- •known or suspected secondary hypertension
- •mean seated Systolic Blood Pressure => 180 mmHg and/or mean seated Diastolic Blood Pressure => 120 mmHg at any visit
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 reach 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 in Trough Seated Diastolic Blood Pressure(End of study (34 weeks or last value on treatment))
- Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7(End of study (34 weeks or last value on treatment))
- Change From Baseline in Trough Seated Systolic Blood Pressure(End of study (34 weeks or last value on treatment))
- Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7(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 Blood Pressure (BP) Normality Classes(End of study (34 weeks or last value on treatment))
- Time to First Additional Antihypertensive(At any point during open-label treatment)
- Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control(At any point during open-label treatment)
- Additional Reduction in DBP by Use of Additional Antihypertensive Therapy(At any point during open-label treatment)
- Additional Reduction in SBP by Use of Additional Antihypertensive Therapy(At any point during open-label treatment)
- Trough DBP Control Pre- and Post- Uptitration(At any point during open-label treatment)
研究者
研究点 (154)
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