Influence of Telmisartan and Lacidipine, Combined or Alone, on QT Interval in Healthy Volunteers
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Telmisartan high (Drug); Telmisartan low (Drug); Lacidipine high (Drug); Lacidipine low (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim
Summary
Assessment of the influence of telmisartan, lacidipine and their combination on the QTC
interval of the ECG
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Average QTcF (QT interval Fridericia correction) change
Secondary outcome: Change in QT intervalChange in QTcB (QT interval Bazett correction) interval Change in PQ interval Change in QRS interval Change in RR interval Change in heart rate (HR) Occurrence of ECG abnormalities Change in T wave morphology Change in U wave morphology Area under the plasma concentration time curve (AUC) Maximum plasma concentration (Cmax) Time to attain maximum plasma concentration (tmax) Trough plasma concentration at steady state (Cmin,ss) Number of participants with adverse events
Eligibility
Minimum age: 21 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
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 Criteria:
- 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
Locations and Contacts
Additional Information
Starting date: September 2001
Last updated: October 14, 2014
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