HealthyPhase 1NCT02264158
Influence of Telmisartan and Lacidipine, Combined or Alone, on QT Interval in Healthy Volunteers
A Phase 1 study testing Telmisartan high, Telmisartan low and Lacidipine high in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Assessment of the influence of telmisartan, lacidipine and their combination on the QTC interval of the ECG Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telmisartan high, Telmisartan low and Lacidipine high
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Mar 2002
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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
About this study
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
Assessment of the influence of telmisartan, lacidipine and their combination on the QTC interval of the ECG
- Conditions
- Healthy
- Being tested
- Telmisartan high, Telmisartan low, Lacidipine high, Lacidipine low, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan highDrug
Telmisartan lowDrug
Lacidipine highDrug
Lacidipine lowDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan high | Experimental | Not described Receives: Drug: Telmisartan high |
| Telmisartan low | Experimental | Not described Receives: Drug: Telmisartan low |
| Lacidipine high | Active comparator | Not described Receives: Drug: Lacidipine high |
| Lacidipine low | Active comparator | Not described Receives: Drug: Lacidipine low |
| Telmisartan+Lacidipine | Experimental | Not described Receives: Drug: Telmisartan low; Drug: Lacidipine low |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average QTcF (QT interval Fridericia correction) change
Measured: baseline, day 1, day 7
Secondary outcomes (14)
Change in QT interval
Measured: baseline, day 1, day 7
Change in QTcB (QT interval Bazett correction) interval
Measured: baseline, day 1, day 7
Change in PQ interval
Measured: baseline, day 1, day 7
Change in QRS interval
Measured: baseline, day 1, day 7
Change in RR interval
Measured: baseline, day 1, day 7
Change in heart rate (HR)
Measured: baseline, day 1, day 7
Occurrence of ECG abnormalities
Measured: baseline, day 1, day 7
Change in T wave morphology
normal, flat, inverted, biphasic
Measured: baseline, day 1, day 7
Change in U wave morphology
normal, abnormal
Measured: baseline, day 1, day 7
Area under the plasma concentration time curve (AUC)
Measured: day 1, day 7
Maximum plasma concentration (Cmax)
Measured: day 1, day 7
Time to attain maximum plasma concentration (tmax)
Measured: day 1, day 7
Trough plasma concentration at steady state (Cmin,ss)
Measured: day 7
Number of participants with adverse events
Measured: up to 8 days after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startSep 2001
- Primary completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264158
- Sponsor's protocol ID
- 502.378
- Status last verified
- Oct 2014
- First submitted
- 14 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02264158
- Acronym / sponsor ID
- 502.378
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Mar 2002 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the influence of telmisartan, lacidipine and their combination on the QTC interval of the ECG
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Average QTcF (QT interval Fridericia correction) change
Time frame: baseline, day 1, day 7
14 secondary outcomes
Change in QT interval
Time frame: baseline, day 1, day 7
Change in QTcB (QT interval Bazett correction) interval
Time frame: baseline, day 1, day 7
Change in PQ interval
Time frame: baseline, day 1, day 7
Change in QRS interval
Time frame: baseline, day 1, day 7
Change in RR interval
Time frame: baseline, day 1, day 7
Change in heart rate (HR)
Time frame: baseline, day 1, day 7
Occurrence of ECG abnormalities
Time frame: baseline, day 1, day 7
Change in T wave morphology
Time frame: baseline, day 1, day 7
Change in U wave morphology
Time frame: baseline, day 1, day 7
Area under the plasma concentration time curve (AUC)
Time frame: day 1, day 7
Maximum plasma concentration (Cmax)
Time frame: day 1, day 7
Time to attain maximum plasma concentration (tmax)
Time frame: day 1, day 7
Trough plasma concentration at steady state (Cmin,ss)
Time frame: day 7
Number of participants with adverse events
Time frame: up to 8 days after last treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telmisartan high, Telmisartan low and Lacidipine high in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average QTcF (QT interval Fridericia correction) change (time frame: baseline, day 1, day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.