Status:
COMPLETED
Influence of Telmisartan and Lacidipine, Combined or Alone, on QT Interval in Healthy Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief Summary
Assessment of the influence of telmisartan, lacidipine and their combination on the QTC interval of the ECG
Eligibility Criteria
Inclusion
- 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/m2.
- In accordance with Good Clinical Practice and local legislation all volunteers will have given their written informed consent prior to admission to the study.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT02264158
Start Date
September 1 2001
Last Update
October 15 2014
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