HypertensionPhase 2NCT02187497
Pharmacokinetics of BIBR 277 in Hypertensive Patients
A Phase 2 study testing Low dose of BIBR 277, Medium dose of BIBR 277 and High dose of BIBR 277 in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
The pharmacokinetic profile of BIBR 277 single dose given in capsule form to hypertensives was evaluated. The results of the present study are to be used in the Japanese population pharmacokinetics analysis Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Low dose of BIBR 277, Medium dose of BIBR 277 and High dose of BIBR 277
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Jun 1998to Sep 1998
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: >=20 years
- Sex: Either male or female
- Patient status: Either inpatient or outpatient, provided that the patient was available for hospitalisation from the day before the trial medication administration until the morning of the day after administration
- BP: Sitting systolic and diastolic blood pressures (SBP and DBP) taken the day before administration should be >= 150 mmHg and >= 90 mmHg, respectively. Patients undergoing treatment with other antihypertensives were not excluded provided the above criteria were satisfied.
Who cannot join
- Malignant hypertension
- Renovascular hypertension
- Severe heart failure (NYHA functional class III - IV), unstable angina pectoris, or history of myocardial infarction (within 6 months of onset)
- Atrioventricular conduction disturbance (degree II to III), atrial fibrillation, or serious arrhythmia
- Symptoms of cerebrovascular disorder
- Serious hepatic dysfunction
Show all 13Show fewer
- Renal function disorder (serum creatinine >= 4.0 mg/dL)
- Known hypersensitivity to angiotensin II receptor antagonists
- Hyperkalaemia (potassium >= 5.5 milliequivalents per liter (mEq/L))
- Treatment with the other investigational drug within 6 months of initiation of the present study
- Pregnant, breast feeding, possibly pregnant or planning to become pregnant during this study
- Previous treatment with the trial medication of the present study
- Otherwise judged ineligible by the investigator
About this study
Official title: BIBR 277 Capsules Pharmacokinetics Study of Hypertensive Patients
The pharmacokinetic profile of BIBR 277 single dose given in capsule form to hypertensives was evaluated. The results of the present study are to be used in the Japanese population pharmacokinetics analysis
- Conditions
- Hypertension
- Being tested
- Low dose of BIBR 277, Medium dose of BIBR 277, High dose of BIBR 277
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of BIBR 277Drug
Medium dose of BIBR 277Drug
High dose of BIBR 277Drug
| Study group | Role | What they receive |
|---|---|---|
| Low dose of BIBR 277 | Experimental | Not described Receives: Drug: Low dose of BIBR 277 |
| Medium dose of BIBR 277 | Experimental | Not described Receives: Drug: Medium dose of BIBR 277 |
| High dose of BIBR 277 | Experimental | Not described Receives: Drug: High dose of BIBR 277 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of BIBR 277 in plasma from 0 to 24 hours (AUC0-24hr)
Measured: Pre-dose up to 24 hours after start of treatment
Mean residence time of BIBR 277 in the body from 0 to 24 hours (MRT0-24hr)
Measured: Pre-dose up to 24 hours after start of treatment
Maximum measured concentration of BIBR 277 in plasma (Cmax)
Measured: Pre-dose up to 24 hours after start of treatment
Time from dosing to the maximum concentration of BIBR 277 in plasma (tmax)
Measured: Pre-dose up to 24 hours after start of treatment
Terminal elimination half-time of BIBR 277 in plasma (t1/2)
Measured: Pre-dose up to 24 hours after start of treatment
Secondary outcomes (4)
Changes from baseline in blood pressure (systolic, diastolic, and mean)
Measured: Pre-dose up to 14 days after start of treatment
Changes from baseline in pulse rate
Measured: Pre-dose up to 14 days after start of treatment
Number of patients with adverse events
Measured: Up to 29 days
Changes from baseline in laboratory test values
Measured: Pre-dose up to 14 days after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJun 1998
- Primary completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 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
- NCT02187497
- Sponsor's protocol ID
- 502.268
- Status last verified
- Jul 2014
- First submitted
- 9 Jul 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIBR 277 Capsules Pharmacokinetics Study of Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02187497
- Acronym / sponsor ID
- 502.268
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 1998
- Primary completion
- Sep 1998 (actual)
- First posted
- 11 Jul 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.
The pharmacokinetic profile of BIBR 277 single dose given in capsule form to hypertensives was evaluated. The results of the present study are to be used in the Japanese population pharmacokinetics analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose of BIBR 277 | Experimental | Drug: Low dose of BIBR 277 |
| Medium dose of BIBR 277 | Experimental | Drug: Medium dose of BIBR 277 |
| High dose of BIBR 277 | Experimental | Drug: High dose of BIBR 277 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: >=20 years
- Sex: Either male or female
- Patient status: Either inpatient or outpatient, provided that the patient was available for hospitalisation from the day before the trial medication administration until the morning of the day after administration
- BP: Sitting systolic and diastolic blood pressures (SBP and DBP) taken the day before administration should be >= 150 mmHg and >= 90 mmHg, respectively. Patients undergoing treatment with other antihypertensives were not excluded provided the above criteria were satisfied.
Key exclusion criteria (13 listed)
- Malignant hypertension
- Renovascular hypertension
- Severe heart failure (NYHA functional class III - IV), unstable angina pectoris, or history of myocardial infarction (within 6 months of onset)
- Atrioventricular conduction disturbance (degree II to III), atrial fibrillation, or serious arrhythmia
- Symptoms of cerebrovascular disorder
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 |
|---|---|---|
| Low dose of BIBR 277 | Drug | Low dose of BIBR 277 |
| Medium dose of BIBR 277 | Drug | Medium dose of BIBR 277 |
| High dose of BIBR 277 | Drug | High dose of BIBR 277 |
Primary outcome
Area under the concentration-time curve of BIBR 277 in plasma from 0 to 24 hours (AUC0-24hr)
Time frame: Pre-dose up to 24 hours after start of treatment
Mean residence time of BIBR 277 in the body from 0 to 24 hours (MRT0-24hr)
Time frame: Pre-dose up to 24 hours after start of treatment
Maximum measured concentration of BIBR 277 in plasma (Cmax)
Time frame: Pre-dose up to 24 hours after start of treatment
Time from dosing to the maximum concentration of BIBR 277 in plasma (tmax)
Time frame: Pre-dose up to 24 hours after start of treatment
Terminal elimination half-time of BIBR 277 in plasma (t1/2)
Time frame: Pre-dose up to 24 hours after start of treatment
4 secondary outcomes
Changes from baseline in blood pressure (systolic, diastolic, and mean)
Time frame: Pre-dose up to 14 days after start of treatment
Changes from baseline in pulse rate
Time frame: Pre-dose up to 14 days after start of treatment
Number of patients with adverse events
Time frame: Up to 29 days
Changes from baseline in laboratory test values
Time frame: Pre-dose up to 14 days after start of 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 11 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
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 2 study testing Low dose of BIBR 277, Medium dose of BIBR 277 and High dose of BIBR 277 in people with Hypertension, 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 4 inclusion and 13 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 11 Jul 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Area under the concentration-time curve of BIBR 277 in plasma from 0 to 24 hours (AUC0-24hr) (time frame: Pre-dose up to 24 hours after start of treatment). The study lists 5 primary outcomes in all. 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 11 Jul 2014.