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

NCT02264158 | Completed Phase 1

• 1 other identifier: 502.378
• Study Type: interventional
• Target: 149
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Average QTcF (QT interval Fridericia correction) change

  baseline, day 1, day 7

Secondary Outcomes (14)

• Change in QT interval

  baseline, day 1, day 7

• Change in QTcB (QT interval Bazett correction) interval

  baseline, day 1, day 7

• Change in PQ interval

  baseline, day 1, day 7

• Change in QRS interval

  baseline, day 1, day 7

• Change in RR interval

  baseline, day 1, day 7

Study Arms (6)

Telmisartan high

EXPERIMENTAL

Drug: Telmisartan high

Telmisartan low

EXPERIMENTAL

Drug: Telmisartan low

Lacidipine high

ACTIVE COMPARATOR

Drug: Lacidipine high

Lacidipine low

ACTIVE COMPARATOR

Drug: Lacidipine low

Telmisartan+Lacidipine

EXPERIMENTAL

Drug: Telmisartan low; Drug: Lacidipine low

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Telmisartan high DRUG

Telmisartan high

Telmisartan low DRUG

Telmisartan low; Telmisartan+Lacidipine

Lacidipine high DRUG

Lacidipine high

Lacidipine low DRUG

Lacidipine low; Telmisartan+Lacidipine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 15, 2014
• Study Start: September 1, 2001
• Primary Completion: March 1, 2002
• Last Updated: October 15, 2014

Record last verified: 2014-10