Trial · NCT00910429
BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension
NCT00910429, Phase 3, Completed, Bayer; results first posted 2020-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension. Trials, record NCT00910429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00910429
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension
- NCT number
- NCT00910429
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 237 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Pulmonary Hypertension
- Interventions
- Riociguat (Adempas, BAY63-2521)
- First posted
- 2009-05-29
- Last updated
- 2023-11-07
- Other registries' IDs
- eudract:2008-003539-19
- Results first posted
- 2020-10-22
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAE) | From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years | Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication. |
| Primary | Number of Participants With Death | From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit) | Analyses of deaths were based on the assessment of causal relationship to study medication. The safety follow-up visit was to be performed 30 days after the last dose of riociguat. |
| Secondary | Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation | From baseline to Termination visit, up to 10 years | Frequency of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study. |
| Secondary | Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation | From baseline to Termination visit, up to 10 years | Frequency of participants only with a treatment-emergent shift in hematology and coagulation parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study. |
| Secondary | Change From Baseline of Hemoglobin in Hematology and Coagulation | From baseline to Termination visit, up to 10 years | Hemoglobin is standard Hematology and coagulation parameter. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study. |
| Secondary | Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry | From baseline to Termination visit, up to 10 years | Frequency of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or low at baseline to a high value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study. |
| Secondary | Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry | From baseline to Termination visit, up to 10 years | Frequency of participants per treatment group only with a treatment-emergent shift in clinical chemistry parameters from normal or high at baseline to a low value at a timepoint after the start of treatment. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study. |
| Secondary | Change From Baseline of Urate in Clinical Chemistry | From baseline to Termination visit, up to 10 years | Urate is standard clinical chemistry parameter. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study. |
| Other | Change of Systolic Blood Pressure (SBP) | From baseline to Termination visit, up to 10 years | SBP was measured after the participant had been at rest for 10 minutes in a supine position. Low SBP was defined as SBP \<95 mmHg, normal SBP as SBP 95-140mmHg, and high SBP as SBP \>140 mmHg. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study. |
| Other | Change of Diastolic Blood Pressure (DBP) | From baseline to Termination visit, up to 10 years | DBP was measured after the participants had been at rest for 10 minutes in a supine position. A termination visit was only to be performed in the case of premature termination of study medication or if the sponsor announced the official end of the study. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAE) | From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Death | From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation | From baseline to Termination visit, up to 10 years | Participants in SAF with evaluable data for each visit, and for each parameter. | Percentage | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation | From baseline to Termination visit, up to 10 years | Participants in SAF with evaluable data for each visit, and for each parameter. | Percentage | NUMBER |
| SECONDARY | Change From Baseline of Hemoglobin in Hematology and Coagulation | From baseline to Termination visit, up to 10 years | Participants in SAF with evaluable data for each visit | gram/deciliter (g/dL) | MEAN |
| SECONDARY | Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry | From baseline to Termination visit, up to 10 years | Participants in SAF with evaluable data for each visit, and for each parameter. | Percentage | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry | From baseline to Termination visit, up to 10 years | Participants in SAF with evaluable data for each visit, and for each parameter. | Percentage | NUMBER |
| SECONDARY | Change From Baseline of Urate in Clinical Chemistry | From baseline to Termination visit, up to 10 years | Participants in SAF with evaluable data for each visit | milligram/deciliter (mg/dL) | MEAN |
| OTHER_PRE_SPECIFIED | Change of Systolic Blood Pressure (SBP) | From baseline to Termination visit, up to 10 years | Participants in SAF with evaluable data for each visit | millimetre(s) of mercury (mmHg) | MEAN |
| OTHER_PRE_SPECIFIED | Change of Diastolic Blood Pressure (DBP) | From baseline to Termination visit, up to 10 years | Participants in SAF with evaluable data for each visit | mmHg | MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group270
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Riociguat-Former Riociguat 1.0-2.5 mg | Any TEAE | 153 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Riociguat-Former Placebo | Any TEAE | 82 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Riociguat-Former Riociguat 1.0-2.5 mg | Any drug-related TEAE | 77 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Riociguat-Former Placebo | Any drug-related TEAE | 44 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Riociguat-Former Riociguat 1.0-2.5 mg | Any serious TEAE | 96 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Riociguat-Former Placebo | Any serious TEAE | 56 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Riociguat-Former Riociguat 1.0-2.5 mg | Any drug-related serious TEAE | 14 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Riociguat-Former Placebo | Any drug-related serious TEAE | 7 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Riociguat-Former Riociguat 1.0-2.5 mg | Any TEAT leading to death | 22 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Riociguat-Former Placebo | Any TEAT leading to death | 13 | Participants |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Riociguat-Former Riociguat 1.0-2.5 mg | 155 | |
| Overall Study | STARTED | Riociguat-Former Placebo | 82 | |
| Overall Study | COMPLETED | Riociguat-Former Riociguat 1.0-2.5 mg | 116 | |
| Overall Study | COMPLETED | Riociguat-Former Placebo | 61 | |
| Overall Study | NOT COMPLETED | Riociguat-Former Riociguat 1.0-2.5 mg | 39 | |
| Overall Study | NOT COMPLETED | Riociguat-Former Placebo | 21 |
Source ClinicalTrials.gov
Adverse events510
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 | Former Riociguat 1.0-2.5 mg | 15 | 155 | 24 |
| other | Anaemia | Blood and lymphatic system disorders | Former Placebo | 9 | 82 | 9 |
| other | Atrial fibrillation | Cardiac disorders | Former Riociguat 1.0-2.5 mg | 12 | 155 | 13 |
| other | Atrial fibrillation | Cardiac disorders | Former Placebo | 6 | 82 | 11 |
| other | Palpitations | Cardiac disorders | Former Riociguat 1.0-2.5 mg | 13 | 155 | 15 |
| other | Palpitations | Cardiac disorders | Former Placebo | 9 | 82 | 11 |
| other | Supraventricular extrasystoles | Cardiac disorders | Former Riociguat 1.0-2.5 mg | 2 | 155 | 3 |
| other | Supraventricular extrasystoles | Cardiac disorders | Former Placebo | 5 | 82 | 8 |
| other | Ventricular extrasystoles | Cardiac disorders | Former Riociguat 1.0-2.5 mg | 4 | 155 | 4 |
| other | Ventricular extrasystoles | Cardiac disorders | Former Placebo | 5 | 82 | 8 |
1 to 10 of 510Source ClinicalTrials.gov
See all 510 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Former Riociguat 1.0-2.5 mg | 22 | 155 |
| Total, all-cause mortality | Former Placebo | 13 | 82 |
| Total, other adverse events | Former Riociguat 1.0-2.5 mg | 148 | 155 |
| Total, other adverse events | Former Placebo | 79 | 82 |
| Total, serious adverse events | Former Riociguat 1.0-2.5 mg | 96 | 155 |
| Total, serious adverse events | Former Placebo | 56 | 82 |
Source ClinicalTrials.gov
Papers6
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 |
|---|---|
| Riociguat-Former Riociguat 1.0-2.5 mg vs Riociguat-Former Placebo: Number of Participants With Death | Trial comparisons |
| Former Riociguat 1.0-2.5 mg vs Former Placebo: deaths from any cause | Trial comparisons |
| Former Riociguat 1.0-2.5 mg vs Former 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/NCT00910429
GET https://conductscience.org/api/trials/v1/NCT00910429/registered?page=2