Clinical Trial: Safety of Terbogrel in Patients With Primary Pulmonary Hypertension

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: An Open-label, Long-term Safety Evaluation of Terbogrel in Patients With Primary Pulmonary Hypertension

Brief 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)

Detailed Summary:
Sponsor: Boehringer Ingelheim

Current 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in patient status [ Time Frame: baseline, up to 18 months ]

change in New York Health Association (NYHA) class, need for treatment with Flolan or transplantation, death


Original Secondary Outcome: Same as current

Information By: Boehringer Ingelheim

Dates:
Date Received: August 21, 2014
Date Started: October 1998
Date Completion:
Last Updated: August 21, 2014
Last Verified: August 2014