HypertensionPhase 2NCT02187484
BIBR 277 Capsules in Hypertensive Patients With Nephropathy
A Phase 2 study testing BIBR 277 in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
The antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were evaluated in hypertensive patients with nephropathy Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- BIBR 277
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Aug 1998to Aug 1999
- 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
- Condition: Either of the following criteria is satisfied in laboratory tests:
- Presence of a renal parenchymal disorder such as chronic glomerulonephritis is confirmed (serum creatinine < 3.0 mg/dL)
- Presence of a renal function disorder (serum creatinine ≥ 1.5 mg/dL to < 3.0 mg/dL)
- Age: ≥ 20 years
- Sex: Either male or female
- Patient status: Either outpatients or inpatients. However, the patient status should remain unchanged throughout the study period
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- Blood pressure (BP):
- [Outpatients] The last 2 measurements of sitting BP out of at least 3 taken during the observation period (2 - 4 weeks) should be stable and a mean of the two measurements should be ≥160 mmHg for systolic BP (SBP) and ≥95 mmHg for diastolic BP (DBP)
- [Inpatients] The last 2 measurements of supine BP taken during the observation period (1 week) should be stable and a mean of the 2 measurements should be ≥ 150 mmHg for SBP and ≥ 90 mmHg for DBP
Who cannot join
- Renovascular hypertension
- Undergoing haemodialysis
- Severe hypertension (Diastolic BP ≥ 120 mmHg)
- Severe heart failure, angina pectoris, or history of myocardial infarction
- Atrioventricular conduction disturbance (degree II to III), atrial fibrillation, or serious arrhythmia
- Symptoms of cerebrovascular disorder
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- Serious hepatic dysfunction
- Uncontrolled diabetes
- Peptic ulcer
- History of hypersensitivity to drugs
- Hyperkalaemia
- Undergoing treatment with a digitalis preparation
- Pregnant, breast feeding, possibly pregnant or planning to become pregnant during this study
- Otherwise judged ineligible by the investigator
About this study
Official title: BIBR 277 Capsules Clinical Study on Hypertension With Nephropathy
The antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were evaluated in hypertensive patients with nephropathy
- Conditions
- Hypertension
- Being tested
- 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.
BIBR 277Drug
| Study group | Role | What they receive |
|---|---|---|
| Single rising doses of BIBR 277 | Experimental | Not described Receives: Drug: BIBR 277 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in hypertensive effect by investigator, using a 5-grade classification
Measured: 8 weeks after start of treatment
Secondary outcomes (7)
Changes from baseline in blood pressure reduction
Measured: 8 weeks after start of treatment
Rate of blood pressure normalisation
percentage of patients with < 150/90 mmHg
Measured: 8 weeks after start of treatment
Changes from baseline in blood pressure / pulse rate
Measured: 8 weeks after start of treatment
Usefulness assessment by investigator, using a 5- grade classification
Measured: 8 weeks after start of treatment
Overall safety assessment by investigator, using a 5- grade classification
Measured: 8 weeks after start of treatment
Number of patients with adverse events
Measured: Up to 12 weeks
Number of patients with abnormal changes in laboratory values
Measured: Up to 8 weeks 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 startAug 1998
- Primary completionAug 1999
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT02187484
- Sponsor's protocol ID
- 502.266
- 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 Clinical Study on Hypertension With Nephropathy
- ClinicalTrials.gov ID
- NCT02187484
- Acronym / sponsor ID
- 502.266
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 1998
- Primary completion
- Aug 1999 (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 antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were evaluated in hypertensive patients with nephropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single rising doses of BIBR 277 | Experimental | Drug: BIBR 277 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Condition: Either of the following criteria is satisfied in laboratory tests:
- Age: ≥ 20 years
- Sex: Either male or female
- Patient status: Either outpatients or inpatients. However, the patient status should remain unchanged throughout the study period
- Blood pressure (BP):
Key exclusion criteria (14 listed)
- Renovascular hypertension
- Undergoing haemodialysis
- Severe hypertension (Diastolic BP ≥ 120 mmHg)
- Severe heart failure, angina pectoris, or history of myocardial infarction
- Atrioventricular conduction disturbance (degree II to III), atrial fibrillation, or serious arrhythmia
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 |
|---|---|---|
| BIBR 277 | Drug | Single rising doses of BIBR 277 |
Primary outcome
Changes from baseline in hypertensive effect by investigator, using a 5-grade classification
Time frame: 8 weeks after start of treatment
7 secondary outcomes
Changes from baseline in blood pressure reduction
Time frame: 8 weeks after start of treatment
Rate of blood pressure normalisation
Time frame: 8 weeks after start of treatment
Changes from baseline in blood pressure / pulse rate
Time frame: 8 weeks after start of treatment
Usefulness assessment by investigator, using a 5- grade classification
Time frame: 8 weeks after start of treatment
Overall safety assessment by investigator, using a 5- grade classification
Time frame: 8 weeks after start of treatment
Number of patients with adverse events
Time frame: Up to 12 weeks
Number of patients with abnormal changes in laboratory values
Time frame: Up to 8 weeks 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.
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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 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 9 inclusion and 14 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?
Changes from baseline in hypertensive effect by investigator, using a 5-grade classification (time frame: 8 weeks after start of treatment). 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.