HypertensionPhase 1NCT01278797

Telmisartan and Amlodipine Versus Monocomponent Tablets

A Phase 1 study testing Telmisartan/Amlodipine Combination Tablet and Amlodipine Monocomponent in people with Hypertension, run by Boehringer Ingelheim at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: Telmisartan/Amlodipine Combination Tablet and Amlodipine Monocomponent
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteCanada
Study dates: Jan 2011to Feb 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy, non-smoking, male and/or post-menopausal/surgically sterile female subjects from 18 to 55 years of age.
Females who participate in this study must either:
be post-menopausal for at least 1 year (no menstrual cycle for 12 consecutive months) and deemed post-menopausal by a physician based on screening clinical laboratory tests (Follicle stimulating hormone (FSH) and Luteinising Hormone (LH)
provide proof of surgical sterility.
Body Mass Index (BMI) greater than or equal to 19.0 and less than or equal to 30.0 kg/m2.
No clinically significant findings in vital signs measurements and systolic blood pressure greater than or equal to 110 mmHg at screening.

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No clinically significant abnormal laboratory values.
No clinically significant findings in a 12-lead electrocardiogram (ECG) and the time between the P and the R waves on the ECG (PR interval) less than or equal to 200 ms at screening.
Have no significant diseases.
Be informed of the nature of the study and give written consent prior to receiving any study procedure.
Have no clinically significant findings from a physical examination.

Who cannot join

Known history or presence of any clinically significant medical condition.
Known or suspected carcinoma.
History or presence of cardiovascular dysfunction (e.g. increased angina, myocardial infarction, outflow obstruction, congestive heart failure).
History of clinically significant hypotension.
Presence of hepatic dysfunction.
Known history or presence of galactose or fructose intolerance, sucrase-isomaltase insufficiency, Lapp lactase insufficiency, galactosemia, or glucose-galactose malabsorption syndrome.

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History of gastrointestinal tract surgery (appendectomy is permitted).
Presence of clinically significant gastrointestinal disease or history of malabsorption within the last year.
Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
History of drug or alcohol addiction requiring treatment.
Positive test result for serum hCG consistent with pregnancy (females only), HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
Positive test result for urine drugs of abuse (cannabinoids, opiates, amphetamines, cocaine, phencyclidine, tricyclic antidepressants, barbiturates, methadone, and benzodiazepines) or urine cotinine.
Difficulty fasting or consuming standard meals.
Females who are pregnant, lactating, or likely to become pregnant during the study.
Does not tolerate venipuncture.
Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
On a special diet within 30 days prior to drug administration (e.g. liquid, protein, raw food diet).
Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.
Donation or loss of whole blood:
Great than or equal to 50 mL and less than or equal to 499 mL within 30 days prior to dosing
greater than or equal to 500 mL within 56 days prior to dosing.
Females who have used hormonal contraceptives within 6 months prior to drug administration.
Have had a tattoo or body piercing within 30 days prior to dosing.
Known history or presence of hypersensitivity or idiosyncratic reaction to telmisartan, amlodipine, or any other drug substances with similar activity.
Use of any drugs known to:
induce (e.g. barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole)
inhibit (e.g. antidepressants (Selective Seratonin Reuptake Inhibitor (SSRI)I), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) hepatic drug metabolism within 30 days prior to drug administration.

Trial locations and contacts

1 site in 1 country.

Canada1 site

1235.41.0001 Boehringer Ingelheim Investigational Site
Toronto, Ontario

Other trials in Canada

About this study

Official title: A Single-Dose, Comparative Bioavailability Study of Telmisartan/Amlodipine 80 mg/10 mg Tablets Versus Micardis 80 mg Tablets With Norvasc 10 mg Tablets Under Fasting Conditions

This study will be an open-label, randomized, two-treatment, two-period, two-sequence crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer Ingelheim Pharma GmbH \& Co. KGs 80 mg telmisartan/10 mg amlodipine fixed dose combination tablet to the corresponding mono-component amlodipine tablets, 10 mg (Pfizers Norvasc).

Conditions: Hypertension
Being tested: Telmisartan/Amlodipine Combination Tablet, Amlodipine Monocomponent
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telmisartan/Amlodipine Combination TabletDrug
Combination Tablet
Amlodipine MonocomponentDrug
Active Comparator

Study groups in NCT01278797
Study group	Role	What they receive
Telmisartan/Amlodipine Fixed Dose	Active comparator	Telmisartan/Amlodipine medium fixed dose combination tablet once daily. Receives: Drug: Telmisartan/Amlodipine Combination Tablet
Amlodipine Monocomponent	Active comparator	Amlodipine Monocomponent 10mg tablet once daily Receives: Drug: Amlodipine Monocomponent

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)
Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method
Measured: Day 1, Day 22
Maximum Observed Plasma Concentration (Cmax) of Amlodipine
Measured: Day 1, Day 22

Secondary outcomes (1)

Time of Maximum Concentration of Amlodipine (TMAX)
Time of maximum measured amlodipine concentration over the zero to 72 hour sampling period
Measured: Day 1, Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Feb 2011

First posted19 Jan 2011 (estimated)
Study startJan 2011
Primary completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01278797
Sponsor's protocol ID: 1235.41
Status last verified: Feb 2014
First submitted: 17 Jan 2011
Last updated: 28 Mar 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Comparative Bioavailability Study of Telmisartan/Amlodipine 80 mg/10 mg Tablets Versus Micardis 80 mg Tablets With Norvasc 10 mg Tablets Under Fasting Conditions
ClinicalTrials.gov ID: NCT01278797
Acronym / sponsor ID: 1235.41
Conditions: Hypertension
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Feb 2011 (actual)
First posted: 19 Jan 2011 (estimated)
Results: Posted 16 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Number of arms: 2

Arm	Type	Receives
Telmisartan/Amlodipine Fixed Dose	Active comparator	Drug: Telmisartan/Amlodipine Combination TabletTelmisartan/Amlodipine medium fixed dose combination tablet once daily.
Amlodipine Monocomponent	Active comparator	Drug: Amlodipine MonocomponentAmlodipine Monocomponent 10mg tablet once daily

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Healthy, non-smoking, male and/or post-menopausal/surgically sterile female subjects from 18 to 55 years of age.
Females who participate in this study must either:
Body Mass Index (BMI) greater than or equal to 19.0 and less than or equal to 30.0 kg/m2.
No clinically significant findings in vital signs measurements and systolic blood pressure greater than or equal to 110 mmHg at screening.
No clinically significant abnormal laboratory values.

Key exclusion criteria (27 listed)

Known history or presence of any clinically significant medical condition.
Known or suspected carcinoma.
History or presence of cardiovascular dysfunction (e.g. increased angina, myocardial infarction, outflow obstruction, congestive heart failure).
History of clinically significant hypotension.
Presence of hepatic dysfunction.

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/Amlodipine Combination TabletCombination Tablet	Drug	Telmisartan/Amlodipine Fixed Dose
Amlodipine MonocomponentActive Comparator	Drug	Amlodipine Monocomponent

Primary outcome

Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)
Time frame: Day 1, Day 22
Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method
Maximum Observed Plasma Concentration (Cmax) of Amlodipine
Time frame: Day 1, Day 22

1 secondary outcome

Time of Maximum Concentration of Amlodipine (TMAX)
Time frame: Day 1, Day 22

Results and safety

Results posted to the registry on 16 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg	14	13
Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg	14	13

Primary outcome: Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)

Time frame: Day 1, Day 22. Mean (Standard Deviation). Unit: nanograms*hour/milliliter

Measure	Telm/Amlo 80 mg/10 mg n = 26	Telm 80 mg + Amlo 10 mg n = 26
Value	260.7971 (60.8717)	276.6315 (66.1935)

Telm/Amlo 80 mg/10 mg vs Telm 80 mg + Amlo 10 mg: Test/Reference ratio of geometric means: 94.51 (90% CI 91.60 to 97.51), p = 0.005, ANOVA

Population analysed: Analysis Set includes all randomized participants who completed the trial

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Amlodipine

Time frame: Day 1, Day 22. Mean (Standard Deviation). Unit: nanograms/milliliter

Measure	Telm/Amlo 80 mg/10 mg n = 26	Telm 80 mg + Amlo 10 mg n = 26
Value	6.7465 (1.3354)	7.2258 (1.6549)

Telm/Amlo 80 mg/10 mg vs Telm 80 mg + Amlo 10 mg: Test/Reference ratio of geometric means: 94.10 (90% CI 90.70 to 97.63), p = 0.0093, ANOVA

Population analysed: Analysis Set includes all randomized participants who completed the trial

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 30 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telm/Amlo 80 mg/10 mg	0 of 27 (0%)	3 of 27 (11.1%)	Not reported
Telm 80 mg + Amlo 10 mg	0 of 27 (0%)	3 of 27 (11.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Telmisartan/Amlodipine Combination Tablet and Amlodipine Monocomponent in people with Hypertension, run by Boehringer Ingelheim at 1 site in Canada.

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 11 inclusion and 27 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 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Yes. Results are posted in the registry (first posted 16 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72) (time frame: Day 1, Day 22). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01278797.

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 28 Mar 2014.