---
title: Placebo Controlled Trial of Bosentan in Scleroderma Patients
nct_id: NCT00377455
overall_status: TERMINATED
phase: PHASE2
sponsor: Georgetown University
study_type: INTERVENTIONAL
primary_condition: Systemic Scleroderma
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00377455.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00377455"
ct_last_update_post_date: 2018-05-24
last_seen_at: "2026-05-12T07:32:27.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Placebo Controlled Trial of Bosentan in Scleroderma Patients

**Official Title:** Placebo Controlled Trial of Bosentan vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary Hypertension

**NCT ID:** [NCT00377455](https://clinicaltrials.gov/study/NCT00377455)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Study was terminated due to inadequate enrolment
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 5
- **Lead Sponsor:** Georgetown University
- **Collaborators:** Actelion
- **Conditions:** Systemic Scleroderma, Pulmonary Hypertension
- **Start Date:** 2006-09
- **Completion Date:** 2010-03
- **CT.gov Last Update:** 2018-05-24

## Brief Summary

The purpose of this study is to determine whether the drug Bosentan improves exercise tolerance in scleroderma patients.

## Detailed Description

Pulmonary hypertension (PAH) is a common and usually fatal form of lung disease in systemic sclerosis (SSc). Multiple drugs have been approved for the treatment of New York Heart Association (NYHA)Class III/IV PAH in scleroderma. Bosentan is an endothelin-1 antagonist which showed significant improvement in distance walked during 12 week clinical trials in PAH patients (7). Therapy for asymptomatic systemic sclerosis patients diagnosed incidentally with PAH (World Health Organization (WHO) Functional Class I) remains controversial. We hypothesize that asymptomatic or minimally symptomatic patients with systemic sclerosis and normal resting pulmonary artery pressures who demonstrate an abnormal rise in pulmonary artery systolic pressure with stress Doppler echocardiography testing represent a subset of patients who already have pulmonary vascular disease and who are at risk for the development of severe PAH. We further hypothesize that early identification and treatment of such patients may retard the progression of that disease.

Hypotheses:

1. Stress echocardiography identifies early pulmonary vascular disease by detecting exercise-induced pulmonary hypertension in patients with systemic sclerosis.
2. Treatment of exercise-induced PAH with Bosentan will lead to improved exercise endurance in patients with systemic sclerosis.

Subjects will be recruited from those patients who have had an abnormal exercise test as part of an earlier study, Exercise Echocardiograms in Scleroderma (IRB# 03-363).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* SSc patients \> 18 with NYHA functional Class I/II symptoms, informed consent, and who are willing to participate in the Pulmonary Hypertension Assessment and Recognition of Outcomes in Scleroderma (PHAROS) long term study (Georgetown IRB 04-227)
* Right heart catheterization with

  1. Normal Mean Pulmonary Arterial Pressure (PAP) at rest
  2. Mean PAP \> 30 with exercise
  3. Wedge Pressure \< 18
* Entry criteria for participating in the exercise echocardiogram study (Georegtown IRB 03-363)

  1. Diffusing Capacity (DLCO) \<60 with a Forced Vital Capacity (FVC) \>60%, or
  2. FVC/DLCO \> 1.6, or
  3. a resting Pulmonary Arterial Systolic Pressure (PASP)\> 40mmHg

Exclusion Criteria:

* Established resting pulmonary hypertension
* Congestive heart failure
* Diastolic dysfunction
* Pregnancy
* Inability to adequately walk/exercise
* Severe liver disease
```

## Arms

- **Bosentan** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **Bosentan** (DRUG) — 62.5 mg by mouth (PO) twice daily (Bid) for 1 month, followed by 125 mg PO Bid thereafter, for a total of 16 weeks
- **Placebo** (DRUG) — 62.5 mg PO Bid for 1 month, followed by 125 mg PO Bid thereafter, for a total of 16 weeks

## Primary Outcomes

- **Total Exercise Time on the Exercise Echocardiogram Using the Standard Bruce Stress Protocol.** _(time frame: This will be determined after 16 weeks on the study medication.)_ — The total exercise time measured using the exercise echocardiogram is evaluated with the standard Bruce Stress Protocol, and this will be determined after 16 weeks on the study medication.

## Secondary Outcomes

- **6-minute Walk Distance** _(time frame: 16 weeks)_
- **Brain Natriuretic Peptide (BNP) Level** _(time frame: 16 weeks)_
- **Endothelin-1(ET-1) Level** _(time frame: 16 weeks)_
- **Quality of Life (QOL)** _(time frame: 16 weeks)_

## Locations (2)

- University of Connecticut, Farmington, Connecticut, United States
- Georgetown University Medical Center, Washington D.C., District of Columbia, United States

## Recent Field Changes (last 30 days)

- `locations.georgetown university medical center|washington d.c.|district of columbia|united states` — added _(2026-05-12)_
- `locations.university of connecticut|farmington|connecticut|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

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