Clinical trial NCT02264158: Influence of Telmisartan and Lacidipine, Combined or Alone, on QT Interval in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-15
Enrollment: 149
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of the influence of telmisartan, lacidipine and their combination on the QTC interval of the ECG


Eligibility 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

Primary outcomes:
measure: Average QTcF (QT interval Fridericia correction) change
timeFrame: baseline, day 1, day 7
Secondary outcomes:
measure: Change in QT interval
timeFrame: baseline, day 1, day 7
measure: Change in QTcB (QT interval Bazett correction) interval
timeFrame: baseline, day 1, day 7
measure: Change in PQ interval
timeFrame: baseline, day 1, day 7
measure: Change in QRS interval
timeFrame: baseline, day 1, day 7
measure: Change in RR interval
timeFrame: baseline, day 1, day 7
measure: Change in heart rate (HR)
timeFrame: baseline, day 1, day 7
measure: Occurrence of ECG abnormalities
timeFrame: baseline, day 1, day 7
measure: Change in T wave morphology
timeFrame: baseline, day 1, day 7
measure: Change in U wave morphology
timeFrame: baseline, day 1, day 7
measure: Area under the plasma concentration time curve (AUC)
timeFrame: day 1, day 7
measure: Maximum plasma concentration (Cmax)
timeFrame: day 1, day 7
measure: Time to attain maximum plasma concentration (tmax)
timeFrame: day 1, day 7
measure: Trough plasma concentration at steady state (Cmin,ss)
timeFrame: day 7
measure: Number of participants with adverse events
timeFrame: up to 8 days after last treatment
Other outcomes:
Locations:
Study officials:
References: