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

Study Overview
=================
Brief Summary
-----------------
Assessment of the influence of telmisartan, lacidipine and their combination on the QTC interval of the ECG

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Telmisartan high
* Drug: Telmisartan low
* Drug: Lacidipine high
* Drug: Lacidipine low
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan high<br> | Drug: Telmisartan high<br> <br> |
| Experimental: Telmisartan low<br> | Drug: Telmisartan low<br> <br> |
| Active Comparator: Lacidipine high<br> | Drug: Lacidipine high<br> <br> |
| Active Comparator: Lacidipine low<br> | Drug: Lacidipine low<br> <br> |
| Experimental: Telmisartan+Lacidipine<br> | Drug: Telmisartan low<br> <br> Drug: Lacidipine low<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |