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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Telmisartan low; Drug: Telmisartan high; Drug: Lacidipine high; Drug: Lacidipine low

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Telmisartan high	Drug: Telmisartan high
Experimental: Telmisartan low	Drug: Telmisartan low
Active Comparator: Lacidipine high	Drug: Lacidipine high
Active Comparator: Lacidipine low	Drug: Lacidipine low
Experimental: Telmisartan+Lacidipine	Drug: Telmisartan low; Drug: Lacidipine low

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average QTcF (QT interval Fridericia correction) change	baseline, day 1, day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in heart rate (HR)		baseline, day 1, day 7
Occurrence of ECG abnormalities		baseline, day 1, day 7
Change in T wave morphology	normal, flat, inverted, biphasic	baseline, day 1, day 7
Change in U wave morphology	normal, abnormal	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
Time to attain maximum plasma concentration (tmax)		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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): March 1, 2002

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 14, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Telmisartan; Lacidipine
• Other Study ID Numbers: 502.378