Trial · NCT00910429
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| 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. |
| Other | Change of Heart Rate | From baseline to Termination visit, up to 10 years | Heart rate was measured after the participant 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. |
| Other | Change of Weight | From baseline to Termination visit, up to 10 years | Weight was evaluated for safety. 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 Oxygen Saturation (SaO2) | From baseline to Termination visit, up to 10 years | SaO2 is one parameters of blood gas. The sample was obtained with the participant resting in a sitting or supine position for at least 10 minutes. 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 Arterial Partial Oxygen Pressure (PaO2) | From baseline to Termination visit, up to 10 years | PaO2 is one parameter of blood gas. The sample was obtained with the participant resting in a sitting or supine position for at least 10 minutes. 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 Arterial Partial Pressure of Carbon Dioxide (PaCO2) | From baseline to Termination visit, up to 10 years | PaCO2 is one parameter of blood gas. The sample was obtained with the participant resting in a sitting or supine position for at least 10 minutes. 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 RR Duration From Electrocardiogram (ECG) | From baseline to Month 48 | Heart rate from ECG is derived from the RR duration, unless arrhythmias such as atrial fibrillation or ventricular extra beats require additional calculations. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position. Analyses up to Month 48. After this timepoint, data was available for considerably fewer participants in the analysis set. |
| Other | Change of PR Duration From ECG | From baseline to Month 48 | PR duration was evaluated as part of ECG. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position. Analyses up to Month 48. After this timepoint, data was available for considerably fewer participants in the analysis set. |
| Other | Change of QRS Duration From ECG | From baseline to Month 48 | QRS duration was evaluated as part of ECG. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position. Analyses up to Month 48. After this timepoint, data was available for considerably fewer participants in the analysis set. |
| Other | Change of QT Duration in ECG | From baseline to Month 48 | QT duration was evaluated as part of ECG. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position. Analyses up to Month 48. After this timepoint, data was available for considerably fewer participants in the analysis set. |
| Other | Change in Six-minute Walking Distance (6MWD) Test | From baseline to End of study visit, up to 10 years | 6MWD is exercise testing and is one of efficacy evaluation |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT00910429/registered