Trial · NCT01416636
Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH)
NCT01416636, Phase 3, Completed, SciPharm SàRL; results first posted 2019-06-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH). Trials, record NCT01416636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01416636
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH)
- NCT number
- NCT01416636
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 105 participants, actual
- Lead sponsor
- SciPharm SàRL
- Conditions
- Non-operable Chronic Thromboembolic Pulmonary Hypertension
- Interventions
- Treprostinil sodium
- First posted
- 2011-08-15
- Last updated
- 2022-06-07
- Results first posted
- 2019-06-10
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in 6-minute Walk Test Distance After 24 Weeks | Baseline and 24 weeks | To determine the effect of subcutaneous Treprostinil sodium on 6-minute walk test distance after 24 weeks in patients with severe non-operable chronic thromboembolic pulmonary hypertension severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension Time frame of the 6-minute walk test: The 6-minute walk test was conducted at the following visits: * baseline (day 1) * Visit 6 (day 168) In case of missing values, Last-Observation-Carried-Forward imputation method was used. In such cases values documented at Visit 4 (day84) were used. |
| Secondary | Number of Participants With Clinical Worsening | 12 weeks and 24 weeks | Clinical worsening defined as a decrease of 6-minute walk test distance of more than 20% from baseline due to Chronic Thromboembolic Pulmonary Hypertension, decrease of New York Heart Association functional class, hospitalization with the requirement for additional Pulmonary Hypertension specific treatment and/or death due to worsening Chronic Thromboembolic Pulmonary Hypertension. Clinical Worsening was assessed after 12 weeks and 24 weeks, participants experiencing clinical worsening at any time-point are reported. |
| Secondary | Effect on Maximal Borg Score During 6-minutes Walk Test | Baseline and 24 weeks | The Borg scale was used for rating of dyspnea during 6-minutes walk test. The scale is defined from 0 to \> 10 (upper bound) (0 = NOTHING AT ALL; 0.5 = VERY VERY SLIGHT (just noticeable); 1 = VERY SLIGHT; 2 = SLIGHT; 3 = MODERATE; 4 = SOMEWHAT SEVERE; 5 = SEVERE; 6-9 = VERY SEVERE; 10 = VERY VERY SEVERE (almost maximum); \>10 MAXIMUM). As can be seen with the scale, the higher scale values represent a worse outcome. As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 48 patients in low dose group. |
| Secondary | Change in WHO/NYHA (World Health Organization - New York Heart Association) Functional Class | Baseline and 24 weeks | Class I - Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope. Class II - Patients with pulmonary hypertension resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III - Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope Class IV - Patients with pulmonary hypertension in the inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity. |
| Secondary | Effect on Quality of Life by the MINNESOTA Questionnaire | Baseline and 24 weeks | This questionnaire is composed of 21 questions relating to limitations in lifestyle associated with Heart Failure. Respondents use a 5-point scale that ranges from 0 (none) to 5 (too much), with a score of 0 representing no limitation and a score of 5 representing maximum limitation. The change in individual score sum was evaluated and is displayed in the results, with a possible range of 0-105. Higher values indicate more limitations in Quality of Life. As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 50 patients randomized to high dose group and 46 patients in low dose group. |
| Secondary | Effect on N-terminal Pro-BNP Levels | Baseline and 24 weeks | baseline values, assessment after 12 and 24 weeks As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 46 patients randomized to high dose group and 46 patients in low dose group. |
| Secondary | Effect on Hemodynamic Parameter (PVR - Pulmonary Vascular Resistance) | Baseline and 24 weeks | baseline values, assessment after 24 weeks As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group. |
| Secondary | Effect on Hemodynamic Parameter (CI - Cardiac Index) | Baseline and 24 weeks | baseline values, assessment after 24 weeks As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group. |
| Secondary | Effect on Hemodynamic Parameter (CO - Cardiac Output) | Baseline and 24 weeks | baseline values, assessment after 24 weeks As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group. |
| Secondary | Effect on Hemodynamic Parameter (mPAP - Mean Pulmonary Arterial Pressure) | Baseline and 24 weeks | baseline values, assessment after 24 weeks As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 47 patients randomized to high dose group and 47 patients in low dose group. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in 6-minute Walk Test Distance After 24 Weeks | Baseline and 24 weeks | All randomized subjects who received at least one dose of study medication. | m | MEAN |
| SECONDARY | Number of Participants With Clinical Worsening | 12 weeks and 24 weeks | All randomized subjects who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Effect on Maximal Borg Score During 6-minutes Walk Test | Baseline and 24 weeks | For this endpoint no imputation role was applied. For 48 patients of the high dose group, as well as for the low dose group, baseline data and also 24 week data are available. | units on a scale | MEAN |
| SECONDARY | Change in WHO/NYHA (World Health Organization - New York Heart Association) Functional Class | Baseline and 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Effect on Quality of Life by the MINNESOTA Questionnaire | Baseline and 24 weeks | units on a scale | MEAN | |
| SECONDARY | Effect on N-terminal Pro-BNP Levels | Baseline and 24 weeks | percentage change to baseline | MEAN | |
| SECONDARY | Effect on Hemodynamic Parameter (PVR - Pulmonary Vascular Resistance) | Baseline and 24 weeks | dyn.s.cm^-5 | MEAN | |
| SECONDARY | Effect on Hemodynamic Parameter (CI - Cardiac Index) | Baseline and 24 weeks | L/min/m2 | MEAN | |
| SECONDARY | Effect on Hemodynamic Parameter (CO - Cardiac Output) | Baseline and 24 weeks | L/min | MEAN | |
| SECONDARY | Effect on Hemodynamic Parameter (mPAP - Mean Pulmonary Arterial Pressure) | Baseline and 24 weeks | mmHg | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in 6-minute Walk Test Distance After 24 Weeks | High Dose | 45.43 | Standard Deviation 71.29 | m | |
| Change in 6-minute Walk Test Distance After 24 Weeks | Low Dose | 3.83 | Standard Deviation 56.21 | m | |
| Number of Participants With Clinical Worsening | High Dose | 7 | Participants | ||
| Number of Participants With Clinical Worsening | Low Dose | 12 | Participants | ||
| Effect on Maximal Borg Score During 6-minutes Walk Test | High Dose | -0.44 | Standard Deviation 2.21 | units on a scale | |
| Effect on Maximal Borg Score During 6-minutes Walk Test | Low Dose | -0.13 | Standard Deviation 2.43 | units on a scale | |
| Change in WHO/NYHA (World Health Organization - New York Heart Association) Functional Class | High Dose | Improved | 27 | Participants | |
| Change in WHO/NYHA (World Health Organization - New York Heart Association) Functional Class | Low Dose | Improved | 9 | Participants | |
| Change in WHO/NYHA (World Health Organization - New York Heart Association) Functional Class | High Dose | No change | 22 | Participants | |
| Change in WHO/NYHA (World Health Organization - New York Heart Association) Functional Class | Low Dose | No change | 36 | Participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treprostinil Sodium High Dose (~30ng/kg/Min) | 53 | |
| Overall Study | STARTED | Treprostinil Sodium Low Dose (~3ng/kg/Min) | 52 | |
| Overall Study | COMPLETED | Treprostinil Sodium High Dose (~30ng/kg/Min) | 45 | |
| Overall Study | COMPLETED | Treprostinil Sodium Low Dose (~3ng/kg/Min) | 46 | |
| Overall Study | NOT COMPLETED | Treprostinil Sodium High Dose (~30ng/kg/Min) | 8 | |
| Overall Study | NOT COMPLETED | Treprostinil Sodium Low Dose (~3ng/kg/Min) | 6 |
Source ClinicalTrials.gov
Adverse events76
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 | Oedema peripheral | Cardiac disorders | High Dose | 7 | 53 | |
| other | Oedema peripheral | Cardiac disorders | Low Dose | 10 | 52 | |
| other | Diarrhoea | Gastrointestinal disorders | High Dose | 33 | 53 | |
| other | Diarrhoea | Gastrointestinal disorders | Low Dose | 12 | 52 | |
| other | Nausea | Gastrointestinal disorders | High Dose | 4 | 53 | |
| other | Nausea | Gastrointestinal disorders | Low Dose | 3 | 52 | |
| other | Vomiting | Gastrointestinal disorders | High Dose | 3 | 53 | |
| other | Vomiting | Gastrointestinal disorders | Low Dose | 3 | 52 | |
| other | Decreased appetite | General disorders | High Dose | 7 | 53 | |
| other | Decreased appetite | General disorders | Low Dose | 0 | 52 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Dose | 2 | 53 |
| Total, all-cause mortality | Low Dose | 1 | 52 |
| Total, other adverse events | High Dose | 53 | 53 |
| Total, other adverse events | Low Dose | 51 | 52 |
| Total, serious adverse events | High Dose | 9 | 53 |
| Total, serious adverse events | Low Dose | 10 | 52 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| High Dose vs Low Dose: Number of Participants With Clinical Worsening | Trial comparisons |
| High Dose vs Low Dose: deaths from any cause | Trial comparisons |
| High Dose vs Low Dose: 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.
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.
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