Safety and Efficacy of Terbogrel in Patients With Primary Pulmonary Hypertension

August 21, 2014 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Terbogrel low dose
Drug: Terbogrel low dose
Experimental: Terbogrel high dose
Drug: Terbogrel high dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in distance walked in 6 minutes
Time Frame: baseline, after 3 months of treatment
baseline, after 3 months of treatment
Change in pulmonary vascular resistance (PVR)
Time Frame: baseline, after 3 months of treatment
baseline, after 3 months of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in pulmonary artery pressure (PAP)
Time Frame: baseline, after 3 months of treatment
baseline, after 3 months of treatment
Change in cardiac index (CI)
Time Frame: baseline, after 3 months of treatment
baseline, after 3 months of treatment
Change in venous oxygen saturation (SvO2 sat.)
Time Frame: baseline, after 3 months of treatment
baseline, after 3 months of treatment
Change in quality of life by SF-36 questionnaire
Time Frame: baseline, after 3 months of treatment
baseline, after 3 months of treatment
Change in chronic heart failure index
Time Frame: baseline, after 3 months of treatment
questionnaire
baseline, after 3 months of treatment
Change in dyspnea/fatigue rating
Time Frame: baseline, after 3 months of treatment
baseline, after 3 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 1998

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 1999

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 528.19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings