Trial · NCT02290613

Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)

NCT02290613, Phase 2, Completed, Heidelberg University; results first posted 2020-04-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH). Trials, record NCT02290613. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02290613

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)
NCT number: NCT02290613
Status: Completed
Phases: Phase 2
Enrollment: 38 participants, actual
Lead sponsor: Heidelberg University
Conditions: Systemic Sclerosis, Pulmonary Hypertension
Interventions: Ambrisentan, Placebo
First posted: 2014-11-14
Last updated: 2020-04-30
Results first posted: 2020-04-30

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Pulmonary Arterial Pressure Change From Baseline	baseline, 6 months	Determine whether mean pulmonary arterial pressure of SSc patients with borderline - PAH (mPAP 21 24 mmHg, TPG \>11 mmHg) can be reduced by 3 mm Hg (absolute change baseline vs. 6 months; equals 15%) following treatment with ambrisentan 10 mg/die (initiated with 5 mg/die and elevated up to 10 mg/die) over 6 months (primary endpoint) compared to baseline and placebo.
Secondary	Mean Pulmonary Arterial Pressure During Exercise Change From Baseline	baseline, 6 months	Determine whether exercise induced elevated mean pulmonary arterial pressure-values (\>30 mmHg without left heart or severe lung disease or systemic arterial hypertension) can be reduced by ambrisentan 10 mg/die over 6 months.
Secondary	6-Minute-walking Test	baseline, 6 months
Secondary	Borg Dyspnea Index	baseline, 6 months	measured directly after 6 minute walking distance; The Borg dyspnea index is an standardized scale which reports the subjective feeling of exertion from 0 (no dyspnea) to 10 (maximal feeling of dyspnea).
Secondary	Quality of Life (SF-36) Questionnaire	baseline, 6 months	SF-36 Questionnaire; physical Summation score; All scores and subscores of the SF-36 questionnaire range from 0 (low quality of life) to 100 (high quality of life). The physical Summation score is a compound score including the physical dimensions of the SF-36.
Secondary	Lung Function	baseline,6 months	DLCo (diffusing capacity or transfer factor of the lung for carbon monoxide (CO))
Secondary	Lung Function	baseline, 6 months	DLCo (diffusing capacity or transfer factor of the lung for carbon monoxide (CO))
Secondary	Lung Function	baseline, 6 months	FVC (forced vital capacity)
Secondary	Lung Function	baseline, 6 months	FEV1 (forced expiratory volume in one second)
Secondary	Lung Function	baseline, 6 months	TLC (total lung capacity)

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Mean Pulmonary Arterial Pressure Change From Baseline	baseline, 6 months	mmHg	MEAN
SECONDARY	Mean Pulmonary Arterial Pressure During Exercise Change From Baseline	baseline, 6 months	mmHg	MEAN
SECONDARY	6-Minute-walking Test	baseline, 6 months	meters	MEAN
SECONDARY	Borg Dyspnea Index	baseline, 6 months	units on a scale	MEAN
SECONDARY	Quality of Life (SF-36) Questionnaire	baseline, 6 months	units on a scale	MEAN
SECONDARY	Lung Function	baseline,6 months	% of target value	MEAN
SECONDARY	Lung Function	baseline, 6 months	mmol/min/kPa	MEAN
SECONDARY	Lung Function	baseline, 6 months	% of target	MEAN
SECONDARY	Lung Function	baseline, 6 months	Litres	MEAN
SECONDARY	Lung Function	baseline, 6 months	Litres	MEAN

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group46

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Pulmonary Arterial Pressure Change From Baseline	Ambrisentan Verum	-1.0	Standard Deviation 6.4	mmHg
Mean Pulmonary Arterial Pressure Change From Baseline	Placebo	-0.73	Standard Deviation 3.6	mmHg
Mean Pulmonary Arterial Pressure During Exercise Change From Baseline	Ambrisentan Verum	-0.73	Standard Deviation 6.23	mmHg
Mean Pulmonary Arterial Pressure During Exercise Change From Baseline	Placebo	1.08	Standard Deviation 7.39	mmHg
6-Minute-walking Test	Ambrisentan Verum	21.53	Standard Deviation 34.6	meters
6-Minute-walking Test	Placebo	-16.53	Standard Deviation 77.32	meters
Borg Dyspnea Index	Ambrisentan Verum	0.62	Standard Deviation 1.7	units on a scale
Borg Dyspnea Index	Placebo	0.08	Standard Deviation 1.54	units on a scale
Quality of Life (SF-36) Questionnaire	Ambrisentan Verum	-6.71	Standard Deviation 12.17	units on a scale
Quality of Life (SF-36) Questionnaire	Placebo	0.87	Standard Deviation 16.01	units on a scale

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ambrisentan Verum	19
Overall Study	STARTED	Placebo	19
Overall Study	COMPLETED	Ambrisentan Verum	17
Overall Study	COMPLETED	Placebo	15
Overall Study	NOT COMPLETED	Ambrisentan Verum	2
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Ambrisentan Verum	6	19	6
other	Headache	Nervous system disorders	Placebo	6	19	6
other	Edema	Cardiac disorders	Ambrisentan Verum	8	19	8
other	Edema	Cardiac disorders	Placebo	4	19	4
other	Dizziness	Nervous system disorders	Ambrisentan Verum	0	19	0
other	Dizziness	Nervous system disorders	Placebo	6	19	6
other	Diarrhea	Gastrointestinal disorders	Ambrisentan Verum	4	19	4
other	Diarrhea	Gastrointestinal disorders	Placebo	2	19	2
other	Paraesthesia	Nervous system disorders	Ambrisentan Verum	4	19	4
other	Paraesthesia	Nervous system disorders	Placebo	0	19	0

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ambrisentan Verum	0	19
Total, all-cause mortality	Placebo	0	19
Total, other adverse events	Ambrisentan Verum	17	19
Total, other adverse events	Placebo	17	19
Total, serious adverse events	Ambrisentan Verum	1	19
Total, serious adverse events	Placebo	5	19

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18506008	BACKGROUND	PubMed
21545989	BACKGROUND	PubMed
31655622	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ambrisentan Verum vs Placebo: deaths from any cause	Trial comparisons
Ambrisentan Verum vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02290613

GET https://conductscience.org/api/trials/v1/NCT02290613/registered?page=2

API reference For AI assistants