NCT02223494

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)

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2000

Completed
14.5 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

1.4 years

First QC Date

August 21, 2014

Last Update Submit

August 21, 2014

Conditions

Hypertension, Pulmonary

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (1)

  • Change in patient status

    baseline, up to 18 months

Study Arms (1)

Terbogrel

EXPERIMENTAL
Drug: Terbogrel

Interventions

TerbogrelDRUG
Terbogrel

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

terbogrel

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 22, 2014

Study Start

October 1, 1998

Primary Completion

March 1, 2000

Last Updated

August 22, 2014

Record last verified: 2014-08