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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lacidipine high; Drug: Telmisartan high; Drug: Placebo; Drug: Telmisartan low; Drug: Lacidipine low

Study type: Interventional

Funder types: Industry

Identifiers

NCT02264158

502.378

Details and patient eligibility

About

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

Enrollment: 149 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

149 participants in 6 patient groups, including a placebo group

Telmisartan high

Experimental group

Treatment:

Drug: Telmisartan high

Telmisartan low

Experimental group

Treatment:

Drug: Telmisartan low

Lacidipine high

Active Comparator group

Treatment:

Drug: Lacidipine high

Lacidipine low

Active Comparator group

Treatment:

Drug: Lacidipine low

Telmisartan+Lacidipine

Experimental group

Treatment:

Drug: Telmisartan low

Drug: Lacidipine low

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo