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NCT01051960 · ClinicalTrials.gov registry record · Phase 4

Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan

A Phase 4 study of Pulmonary Hypertension and Systemic Sclerosis, sponsored by University of California, Los Angeles.

Completed
Registry status
Phase 4
Development phase
12
Enrollment target
1
Study location

NCT01051960: Completed Phase 4 study of Pulmonary Hypertension and Systemic Sclerosis, sponsored by University of California, Los Angeles.

NCT01051960 is a Phase 4 study of Pulmonary Hypertension and Systemic Sclerosis that has completed, run by University of California, Los Angeles. The registered enrollment target is 12 participants, below the 613-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01051960, a Phase 4 study of Pulmonary Hypertension and Systemic Sclerosis, has completed, sponsored by University of California, Los Angeles.

COMPLETED
Registry status
Phase 4
Development phase
12 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine the clinical characteristics and hemodynamic profiles that predict exercise induced pulmonary hypertension in 15 patients with systemic sclerosis. The study also aims to determine the effectiveness of Ambrisentan for subjects with exercise induced Pulmonary Arterial Hypertension (PAH) with scleroderma

Primary Outcome

We defined ePH (exercise PH) as an mPAP of 30 mmHg, PCWP of 18 mm Hg, and a transpulmonary gradient (TPG) of 15 mm Hg, where TPG equals mPAP minus PCWP. We defined ePVH (exercise pulmonary venous hypertension) as an mPAP of 30 mm Hg, PCWP of 18 mm Hg, and a TPG of 15 mm Hg. We defined eoPH (exercise out of proportion) as an mPAP of 30 mm Hg, PCWP of 18 mm Hg, and a TPG of 15 mm Hg (4). Our hypothesis was that SSc patients with normal exercise physiology and ePVH have a different patho-physiology

Interventions

  • DRUG Ambrisentan

Study Locations (1)

California

  • David Geffen School of Medicine, University of California, Los Angeles - Los Angeles

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2009-03
Est. Completion 2011-01
Phase Phase 4

What the finished NCT01051960 record still lists

NCT01051960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 613-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (98% lower).

The record links to 3 conditions, with Pulmonary Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Ambrisentan is the first listed.

NCT01051960 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT01051960 about?

NCT01051960 is a clinical study titled "Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan". The purpose of this study is to determine the clinical characteristics and hemodynamic profiles that predict exercise induced pulmonary hypertension in 15 patients with systemic sclerosis. The study also aims to determine the effectiveness of Ambrisentan for subjects with exercise induced Pulmonary ...

What is the current status of trial NCT01051960?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2009-03. Estimated completion is 2011-01.

What conditions does trial NCT01051960 study?

This clinical trial studies the following conditions: Pulmonary Hypertension, Systemic Sclerosis, Shortness of Breath.

What interventions are being tested in trial NCT01051960?

The interventions under investigation include: Ambrisentan (DRUG).

Who is sponsoring clinical trial NCT01051960?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01051960 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pulmonary Hypertension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01051960's enrollment target sits among peer trials

12 66th of 72 higher than 7 of 72 other Pulmonary Hypertension trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pulmonary Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01051960, the US trial registry maintained by the National Library of Medicine. NCT01051960 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.