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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terbogrel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terbogrel | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | up to 18 months | |
| Number of patients with clinically significant findings in laboratory tests | up to 18 months | |
| Number of patients with clinically significant changes in ECG | up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient status | change in New York Health Association (NYHA) class, need for treatment with Flolan or transplantation, death | baseline, up to 18 months |
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Inclusion Criteria:
Patients who
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C112331 | terbogrel |
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| D002318 |
| Cardiovascular Diseases |