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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 interval

Change 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

Page last updated: August 23, 2015

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