Hypertension, PulmonaryPhase 2NCT02223481
Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension
A Phase 2 study testing Terbogrel low dose and Terbogrel high dose in people with Hypertension, Pulmonary, run by Boehringer Ingelheim.
Trial summary
This study sought to determine whether terbogrel was an effective treatment for primary pulmonary hypertension (PPH) by comparing its efficacy and safety to that of placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Terbogrel low dose and Terbogrel high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- May 1998to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary pulmonary hypertension and New York Health Association (NYHA) chronic heart failure (CHF) functional class II-III
- Ability to walk >= 50 meters on the 6 minute walk test
- Resting mean pulmonary artery pressure > 25 mmHg
- Mean right atrial pressure <= 20 mmHg
- Pulmonary capillary wedge pressure <= 15 mmHg
- Cardiac index > 2.5 L/min2
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- SvO2 sat. > 63%
- Male of female at least 18 years old
- Signed written informed consent
Who cannot join
- Secondary pulmonary hypertension due to lung or systemic diseases
- Pregnant of nursing women, or women of childbearing potential who are not using adequate methods of birth control
- Concurrent systematic use of aspirin, aspirin like drugs, or non-steroidal anti-inflammatory drugs (NSAIDs)
- Surgery of bleeding from gastrointestinal, genitourinary tract, cerebrum or retina within past 6 weeks
- History of bleeding diathesis or a platelet count less than 70,000/mm3
- Exercise limited by factors other than fatigue or exertional dyspnea, such as arthritis, claudication, angina, chronic obstructive pulmonary disease, or bronchial asthma
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- Myocardial infarction, stroke, or transient ischemic attack within the preceding six months
- Systolic blood pressure < 90 mmHg or > 180 mmHg, or diastolic blood pressure > 110 mmHg
- Known drug or alcohol dependency within one year of entry into the study
- Known hypersensitivity to any component of the study formulation, epoprostenol, nitric oxide, or adenosine
- Psychiatric or other illness or condition which, in the opinion of the principal investigator, may interfere with study participation, compliance, or other elements of the protocol
- Participation in an evaluation of an investigational drug within the past 30 days
- Portal hypertension or cirrhosis of the liver
- Congenital heart disease e.g., atrial septal defect; patent foramen ovale does not exclude patient from the study
- Appetite suppressants such as fenfluramine, dexfenfluramine, and inhibitors of serotonin uptake known to be associated with primary pulmonary hypertension, received within 3 months of entry into the study
- HIV positive
- Vasodilators. Patients will not receive Ca-channel blockers during the study unless the medication was started prior to the study and the patient has been on a stable dose for at least one month prior to entry
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension
This study sought to determine whether terbogrel was an effective treatment for primary pulmonary hypertension (PPH) by comparing its efficacy and safety to that of placebo.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Terbogrel low dose, Terbogrel high dose, Placebo
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbogrel low doseDrug
Terbogrel high doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Terbogrel low dose | Experimental | Not described Receives: Drug: Terbogrel low dose |
| Terbogrel high dose | Experimental | Not described Receives: Drug: Terbogrel high dose |
| 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.
Change in distance walked in 6 minutes
Measured: baseline, after 3 months of treatment
Change in pulmonary vascular resistance (PVR)
Measured: baseline, after 3 months of treatment
Secondary outcomes (6)
Change in pulmonary artery pressure (PAP)
Measured: baseline, after 3 months of treatment
Change in cardiac index (CI)
Measured: baseline, after 3 months of treatment
Change in venous oxygen saturation (SvO2 sat.)
Measured: baseline, after 3 months of treatment
Change in quality of life by SF-36 questionnaire
Measured: baseline, after 3 months of treatment
Change in chronic heart failure index
questionnaire
Measured: baseline, after 3 months of treatment
Change in dyspnea/fatigue rating
Measured: baseline, after 3 months of treatment
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 startMay 1998
- Primary completionSep 1999
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 71 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
- NCT02223481
- Sponsor's protocol ID
- 528.19
- 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
- A Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02223481
- Acronym / sponsor ID
- 528.19
- Conditions
- Hypertension, Pulmonary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 1998
- Primary completion
- Sep 1999 (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.
This study sought to determine whether terbogrel was an effective treatment for primary pulmonary hypertension (PPH) by comparing its efficacy and safety to that of placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Terbogrel low dose | Experimental | Drug: Terbogrel low dose |
| Terbogrel high dose | Experimental | Drug: Terbogrel high dose |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Primary pulmonary hypertension and New York Health Association (NYHA) chronic heart failure (CHF) functional class II-III
- Ability to walk >= 50 meters on the 6 minute walk test
- Resting mean pulmonary artery pressure > 25 mmHg
- Mean right atrial pressure <= 20 mmHg
- Pulmonary capillary wedge pressure <= 15 mmHg
Key exclusion criteria (17 listed)
- Secondary pulmonary hypertension due to lung or systemic diseases
- Pregnant of nursing women, or women of childbearing potential who are not using adequate methods of birth control
- Concurrent systematic use of aspirin, aspirin like drugs, or non-steroidal anti-inflammatory drugs (NSAIDs)
- Surgery of bleeding from gastrointestinal, genitourinary tract, cerebrum or retina within past 6 weeks
- History of bleeding diathesis or a platelet count less than 70,000/mm3
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 low dose | Drug | Terbogrel low dose |
| Terbogrel high dose | Drug | Terbogrel high dose |
| Placebo | Drug | Placebo |
Primary outcome
Change in distance walked in 6 minutes
Time frame: baseline, after 3 months of treatment
Change in pulmonary vascular resistance (PVR)
Time frame: baseline, after 3 months of treatment
6 secondary outcomes
Change in pulmonary artery pressure (PAP)
Time frame: baseline, after 3 months of treatment
Change in cardiac index (CI)
Time frame: baseline, after 3 months of treatment
Change in venous oxygen saturation (SvO2 sat.)
Time frame: baseline, after 3 months of treatment
Change in quality of life by SF-36 questionnaire
Time frame: baseline, after 3 months of treatment
Change in chronic heart failure index
Time frame: baseline, after 3 months of treatment
Change in dyspnea/fatigue rating
Time frame: baseline, after 3 months 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 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 low dose and Terbogrel high dose 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 9 inclusion and 17 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 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. 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 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?
Change in distance walked in 6 minutes (time frame: baseline, after 3 months of treatment). 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?
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.