NCT02223481

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Status
completed

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

May 1, 1998

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1999

Completed
15 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

1.3 years

First QC Date

August 21, 2014

Last Update Submit

August 21, 2014

Conditions

Hypertension, Pulmonary

Outcome Measures

Primary Outcomes (2)

  • Change in distance walked in 6 minutes

    baseline, after 3 months of treatment

  • Change in pulmonary vascular resistance (PVR)

    baseline, after 3 months of treatment

Secondary Outcomes (6)

  • Change in pulmonary artery pressure (PAP)

    baseline, after 3 months of treatment

  • Change in cardiac index (CI)

    baseline, after 3 months of treatment

  • Change in venous oxygen saturation (SvO2 sat.)

    baseline, after 3 months of treatment

  • Change in quality of life by SF-36 questionnaire

    baseline, after 3 months of treatment

  • Change in chronic heart failure index

    baseline, after 3 months of treatment

  • +1 more secondary outcomes

Study Arms (3)

Terbogrel low dose

EXPERIMENTAL
Drug: Terbogrel low dose

Terbogrel high dose

EXPERIMENTAL
Drug: Terbogrel high dose

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Terbogrel low doseDRUG
Terbogrel low dose
Terbogrel high doseDRUG
Terbogrel high dose
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • SvO2 sat. \> 63%
  • Male of female at least 18 years old
  • Signed written informed consent

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

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
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 22, 2014

Study Start

May 1, 1998

Primary Completion

September 1, 1999

Last Updated

August 22, 2014

Record last verified: 2014-08