Trial · NCT00855465
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.
NCT00855465, Phase 3, Completed, Bayer; results first posted 2014-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH. Trials, record NCT00855465. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00855465
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.
- NCT number
- NCT00855465
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 262 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Pulmonary Hypertension
- Interventions
- Riociguat (Adempas, BAY63-2521), Placebo
- First posted
- 2009-03-04
- Last updated
- 2023-11-21
- Other registries' IDs
- eudract:2007-000072-16
- Results first posted
- 2014-03-11
Source ClinicalTrials.gov
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16 | Baseline and week 16 | 6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity. |
| Secondary | Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16 | Baseline and week 16 | The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80\*(PAPmean - PCWP)/CO |
| Secondary | N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16 | Baseline and week 16 | N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure. |
| Secondary | World Health Organization (WHO) Functional Class - Change From Baseline to Week 16 | Baseline and week 16 | The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH. |
| Secondary | Percentage of Participants With Clinical Worsening | At week 16 | The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; rescue endarterectomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH. |
| Secondary | Borg CR 10 Scale - Change From Baseline to Week 16 | Baseline and week 16 | The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal"). |
| Secondary | EQ-5D Utility Score - Change From Baseline to Week 16 | Baseline and week 16 | EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions). |
| Secondary | Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 16 | Baseline and week 16 | The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The LPH total score can range from 0 (best) to 105 (worst). |
| Other | All Caused Mortality | At visit 6 (week 16) | All cause mortality (including cardiovascular mortality) was one component of the composite endpoint "time to clinical worsening". |
| Other | Mean Pulmonary Artery Pressure (PAPmean) - Change From Baseline to Week 16 | Baseline and week 16 | Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization. |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16 | Baseline and week 16 | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. | Meters | MEAN |
| SECONDARY | Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16 | Baseline and week 16 | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PVR. | dyn*s*cm^-5 | MEAN |
| SECONDARY | N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16 | Baseline and week 16 | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of NT-proBNP. | pg/mL | MEAN |
| SECONDARY | World Health Organization (WHO) Functional Class - Change From Baseline to Week 16 | Baseline and week 16 | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of WHO functional class. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Worsening | At week 16 | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. | Percentage of participants | NUMBER |
| SECONDARY | Borg CR 10 Scale - Change From Baseline to Week 16 | Baseline and week 16 | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. | Scores on a scale | MEAN |
| SECONDARY | EQ-5D Utility Score - Change From Baseline to Week 16 | Baseline and week 16 | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the EQ5D utility score. | Scores on a scale | MEAN |
| SECONDARY | Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 16 | Baseline and week 16 | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the LPH questionnaire. | Scores on a scale | MEAN |
| OTHER_PRE_SPECIFIED | All Caused Mortality | At visit 6 (week 16) | Intent to Treat (ITT) - a randomized subject was valid for ITT analyses if at least one dose of study medication was administered. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Mean Pulmonary Artery Pressure (PAPmean) - Change From Baseline to Week 16 | Baseline and week 16 | Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.~Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PAPmean. | mmHg | MEAN |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16 | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | 38.9 | Standard Deviation 79.3 | Meters | |
| 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16 | Placebo | -5.5 | Standard Deviation 84.3 | Meters | |
| Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16 | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | -225.68 | Standard Deviation 247.52 | dyn*s*cm^-5 | |
| Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16 | Placebo | 23.07 | Standard Deviation 273.53 | dyn*s*cm^-5 | |
| N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16 | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | -290.69 | Standard Deviation 1716.90 | pg/mL | |
| N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16 | Placebo | 76.35 | Standard Deviation 1446.63 | pg/mL | |
| World Health Organization (WHO) Functional Class - Change From Baseline to Week 16 | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | -2 | 2.3 | Percentage of Participants | |
| World Health Organization (WHO) Functional Class - Change From Baseline to Week 16 | Placebo | -2 | 0 | Percentage of Participants | |
| World Health Organization (WHO) Functional Class - Change From Baseline to Week 16 | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | -1 | 30.6 | Percentage of Participants | |
| World Health Organization (WHO) Functional Class - Change From Baseline to Week 16 | Placebo | -1 | 14.9 | Percentage of Participants |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | 174 | |
| Treatment Period | STARTED | Placebo | 88 | |
| Treatment Period | Participants Received Treatment | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | 173 | |
| Treatment Period | Participants Received Treatment | Placebo | 88 | |
| Treatment Period | COMPLETED | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | 160 | |
| Treatment Period | COMPLETED | Placebo | 83 | |
| Treatment Period | NOT COMPLETED | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | 14 | |
| Treatment Period | NOT COMPLETED | Placebo | 5 | |
| Follow-up Period (FUP) | STARTED | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | 17 | |
| Follow-up Period (FUP) | STARTED | Placebo | 4 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events238
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 | Anaemia | Blood and lymphatic system disorders | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | 5 | 173 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 88 | |
| other | Bradycardia | Cardiac disorders | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | 1 | 173 | |
| other | Bradycardia | Cardiac disorders | Placebo | 2 | 88 | |
| other | Palpitations | Cardiac disorders | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | 6 | 173 | |
| other | Palpitations | Cardiac disorders | Placebo | 4 | 88 | |
| other | Right ventricular failure | Cardiac disorders | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | 2 | 173 | |
| other | Right ventricular failure | Cardiac disorders | Placebo | 2 | 88 | |
| other | Ventricular extrasystoles | Cardiac disorders | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | 0 | 173 | |
| other | Ventricular extrasystoles | Cardiac disorders | Placebo | 2 | 88 |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | 146 | 173 |
| Total, other adverse events | Placebo | 67 | 88 |
| Total, serious adverse events | Riociguat (Adempas, BAY63-2521)_individual Dose Titration | 34 | 173 |
| Total, serious adverse events | Placebo | 14 | 88 |
Source ClinicalTrials.gov
Papers11
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Riociguat (Adempas, BAY63-2521)_individual Dose Titration vs Placebo: All Caused Mortality | Trial comparisons |
| Riociguat (Adempas, BAY63-2521)_individual Dose Titration 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.
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/NCT00855465
GET https://conductscience.org/api/trials/v1/NCT00855465/registered?page=2