NCT02264158已完成1 期
A Double-blind, Randomised, Placebo Controlled, 6 Parallel Groups Study to Assess the Influence of Telmisartan (40 mg or 160 mg), Lacidipine (4 mg or 6 mg) and Their Combination (Telmisartan 40 mg and Lacidipine 4 mg) p.o. Once Daily for Seven Days on the QT Interval of the ECG in Healthy Male and Female Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 149
- 主要终点
- Average QTcF (QT interval Fridericia correction) change
研究概览
简要总结
Assessment of the influence of telmisartan, lacidipine and their combination on the QTC interval of the ECG
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants in the study should be healthy males/females, range from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m
- •In accordance with Good Clinical Practice and local legislation all volunteers will have given their written informed consent prior to admission to the study.
排除标准
- •Any finding of the medical examination (including blood pressure, heart rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (>24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
- •Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- •Participation in another tiral with an investigational drug (<= two months prior to administration or during the trial)
- •Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation (>= 100 ml within four weeks prior to administration or during the trial)
- •Any laboratory value outside the clinically accepted reference range
- •Excessive physical activities within the last week before the trial or during the trial
- •Following exclusion criteria are of special interest for this study:
- •Hypersensitivity to telmisartan, lacidipine and/or related drugs of these classes
- •Supine blood pressure at screening of systolic <= 110 mmHg and diastolic <= 60 mmHg
- •Any ECG value outside of the reference range of clinical relevance, but not limited to PR interval > 240 ms, QRS interval > 110 ms, QTcB > 470 ms for females and QTcB > 450 ms for males
- •For female subjects:
- •Pregnancy
- •Positive pregnancy test
- •No adequate contraception (adequate contraception e.g. sterilisation, intrauterine pessary (IUP), oral contraceptives)
- •Inability to maintain this adequate contraception during the whole study period
- •Lactation period
研究组 & 干预措施
Telmisartan high
Experimental
干预措施: Telmisartan high (Drug)
Telmisartan low
Experimental
干预措施: Telmisartan low (Drug)
Lacidipine high
Active Comparator
干预措施: Lacidipine high (Drug)
Lacidipine low
Active Comparator
干预措施: Lacidipine low (Drug)
Telmisartan+Lacidipine
Experimental
干预措施: Telmisartan low (Drug)
Telmisartan+Lacidipine
Experimental
干预措施: Lacidipine low (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Average QTcF (QT interval Fridericia correction) change
时间窗: baseline, day 1, day 7
次要结局
- Change in RR interval(baseline, day 1, day 7)
- Change in U wave morphology(baseline, day 1, day 7)
- Change in QTcB (QT interval Bazett correction) interval(baseline, day 1, day 7)
- Change in PQ interval(baseline, day 1, day 7)
- Change in heart rate (HR)(baseline, day 1, day 7)
- Change in T wave morphology(baseline, day 1, day 7)
- Time to attain maximum plasma concentration (tmax)(day 1, day 7)
- Change in QRS interval(baseline, day 1, day 7)
- Change in QT interval(baseline, day 1, day 7)
- Occurrence of ECG abnormalities(baseline, day 1, day 7)
- Area under the plasma concentration time curve (AUC)(day 1, day 7)
- Maximum plasma concentration (Cmax)(day 1, day 7)
- Trough plasma concentration at steady state (Cmin,ss)(day 7)
- Number of participants with adverse events(up to 8 days after last treatment)
研究者
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