Hypertension, PulmonaryPhase 2NCT02223494
Safety of Terbogrel in Patients With Primary Pulmonary Hypertension
A Phase 2 study testing Terbogrel in people with Hypertension, Pulmonary, run by Boehringer Ingelheim.
Trial summary
Study to assess the safety of terbogrel during open-label, long-term treatment in medically stable or improving patients with primary pulmonary hypertension who have completed the 12-week, double-blind randomized trial of terbogrel (protocol 528.19) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Terbogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Oct 1998to Mar 2000
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who
- completed the preceding primary pulmonary hypertension, double-blinded clinical trial of terbogrel (protocol 528.19)
- provide informed consent to participate in this trial
- are in a stable or improving medical condition, in the opinion of the investigator
- enter the study immediately upon their completion of the preceding double-blind Trial 528.19, or enter the study within one month of completing the preceding trial as long as their medical condition has remained stable or continues to improve in the interim
Who cannot join
- Development of an unstable medical condition during or following completion of the preceding clinical trial which, in the investigator's opinion, may be worsened by treatment with terbogrel
- Premature discontinuation of the preceding terbogrel clinical trial due to an adverse event or for any other reason
- Pregnant or nursing women, or women of childbearing potential (less than one year postmenopausal or not surgically sterilized) who are not using adequate methods of birth control
About this study
Official title: An Open-label, Long-term Safety Evaluation of Terbogrel in Patients With Primary Pulmonary Hypertension
Study to assess the safety of terbogrel during open-label, long-term treatment in medically stable or improving patients with primary pulmonary hypertension who have completed the 12-week, double-blind randomized trial of terbogrel (protocol 528.19)
- Conditions
- Hypertension, Pulmonary
- Being tested
- Terbogrel
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerbogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Terbogrel | Experimental | Not described Receives: Drug: Terbogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: up to 18 months
Number of patients with clinically significant findings in laboratory tests
Measured: up to 18 months
Number of patients with clinically significant changes in ECG
Measured: up to 18 months
Secondary outcomes (1)
Change in patient status
change in New York Health Association (NYHA) class, need for treatment with Flolan or transplantation, death
Measured: baseline, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startOct 1998
- Primary completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies 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
- 33 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
- NCT02223494
- Sponsor's protocol ID
- 528.21
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Long-term Safety Evaluation of Terbogrel in Patients With Primary Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02223494
- Acronym / sponsor ID
- 528.21
- Conditions
- Hypertension, Pulmonary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 1998
- Primary completion
- Mar 2000 (actual)
- First posted
- 22 Aug 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.
Study to assess the safety of terbogrel during open-label, long-term treatment in medically stable or improving patients with primary pulmonary hypertension who have completed the 12-week, double-blind randomized trial of terbogrel (protocol 528.19)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Terbogrel | Experimental | Drug: Terbogrel |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who
- completed the preceding primary pulmonary hypertension, double-blinded clinical trial of terbogrel (protocol 528.19)
- provide informed consent to participate in this trial
- are in a stable or improving medical condition, in the opinion of the investigator
- enter the study immediately upon their completion of the preceding double-blind Trial 528.19, or enter the study within one month of completing the preceding trial as long as their medical condition has remained stable or continues to improve in the interim
Key exclusion criteria (3 listed)
- Development of an unstable medical condition during or following completion of the preceding clinical trial which, in the investigator's opinion, may be worsened by treatment with terbogrel
- Premature discontinuation of the preceding terbogrel clinical trial due to an adverse event or for any other reason
- Pregnant or nursing women, or women of childbearing potential (less than one year postmenopausal or not surgically sterilized) who are not using adequate methods of birth control
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 |
|---|---|---|
| Terbogrel | Drug | Terbogrel |
Primary outcome
Number of patients with adverse events
Time frame: up to 18 months
Number of patients with clinically significant findings in laboratory tests
Time frame: up to 18 months
Number of patients with clinically significant changes in ECG
Time frame: up to 18 months
1 secondary outcome
Change in patient status
Time frame: baseline, up to 18 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 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 Terbogrel in people with Hypertension, Pulmonary, 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 22 Aug 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 was stopped early. Results are not available in the source record.
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?
Number of patients with adverse events (time frame: up to 18 months). The study lists 3 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 22 Aug 2014.