Influence of Telmisartan and Lacidipine, Combined or Alone, on QT Interval in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Telmisartan low; Drug: Placebo; Drug: Telmisartan high; Drug: Lacidipine high; Drug: Lacidipine low

• Registration Number: NCT02264158
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2002-03
• Status Verified: 2014-10
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-14
• Last Update Submitted: 2014-10-14
• Study First Posted: 2014-10-15
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telmisartan+Lacidipine	Telmisartan low	-
Placebo	Placebo	-
Telmisartan high	Telmisartan high	-
Telmisartan low	Telmisartan low	-
Lacidipine high	Lacidipine high	-
Lacidipine low	Lacidipine low	-
Telmisartan+Lacidipine	Lacidipine low	-

Primary Outcome Measures

Name	Time	Method
Average QTcF (QT interval Fridericia correction) change	baseline, day 1, day 7

Secondary Outcome Measures

Name	Time	Method
Change in QRS interval	baseline, day 1, day 7
Change in RR interval	baseline, day 1, day 7
Change in U wave morphology	baseline, day 1, day 7	normal, abnormal
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	normal, flat, inverted, biphasic
Time to attain maximum plasma concentration (tmax)	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