Trial · NCT01786512
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours, and 7 days post-dose. | The pharmacokinetic analysis set (PKAS) included all randomized participants who received at least 1 dose of OM and had at least 1 evaluable OM PK parameter. | ng/mL | MEAN |
| PRIMARY | Dose Escalation Phase: Time to Maximum Observed Plasma Concentration (Tmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours, and 7 days post-dose. | Pharmacokinetic analysis set | hours | MEAN |
| PRIMARY | Dose Escalation Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing on Day 7 | Day 7 at predose | Pharmacokinetic analysis set | ng/mL | MEAN |
| PRIMARY | Dose Escalation Phase: Area Under the Plasma Concentration-time Curve for a Dosing Interval of 12 Hours Post Dose (AUC12) for Omecamtiv Mecarbil | Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dose | Pharmacokinetic analysis set | ng*hr/mL | MEAN |
| PRIMARY | Expansion Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing | Predose (before morning dose) at weeks 2, 8, 12, 16, and 20 | Pharmacokinetic analysis set with available data at each time point. | ng/mL | MEAN |
| PRIMARY | Expansion Phase: Maximum Observed Plasma Concentration of Omecamtiv Mecarbil | Weeks 2 and 12 at predose and 1, 2, 4, 6, and 8 hours post-dose. | Pharmacokinetic analysis set with available data at each time point. | ng/mL | MEAN |
| SECONDARY | Expansion Phase: Change From Baseline in Systolic Ejection Time (SET) at Week 20 | Baseline and week 20 | The full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Expansion Phase: Change From Baseline in Stroke Volume at Week 20 | Baseline and week 20 | The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Expansion Phase: Change From Baseline in Left Ventricular End Systolic Diameter (LVESD) at Week 20 | Baseline and week 20 | The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | Expansion Phase: Change From Baseline in Left Ventricular End Diastolic Diameter (LVEDD) at Week 20 | Baseline and week 20 | The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | Expansion Phase: Change From Baseline in Heart Rate at Week 20 | Baseline and week 20 | The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values. | bpm | LEAST_SQUARES_MEAN |
| SECONDARY | Expansion Phase: Change From Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP) at Week 20 | Baseline and week 20 | The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values. | pg/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events | From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase. | Participants randomized in the dose-escalation phase who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Expansion Phase: Number of Participants With Treatment-emergent Adverse Events | From first dose of study drug until 4 weeks after last dose; treatment duration was 20 weeks in the expansion phase. | All participants randomized in the expansion phase who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT01786512/outcomes