Trial · NCT03001011
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 | Change From Baseline in Serum Phosphorus at Week 8 | Baseline, Week 8 | Modified intention to treat (mITT) population: all participants who were randomized, received at least 1 dose of IMP \& had both baseline assessment \& at least 1 post-baseline assessment of phosphorus measure. Here, number analyzed = participants with available data at specified time points. | mmol/L | MEDIAN |
| SECONDARY | Change From Baseline in Total Cholesterol at Week 8 | Baseline, Week 8 | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | mmol/L | MEDIAN |
| SECONDARY | Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 | Baseline, Week 8 | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | mmol/L | MEDIAN |
| SECONDARY | Change From Baseline in Calcium-Phosphorus Product at Week 8 | Baseline, Week 8 | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | mmol^2/L^2 | MEDIAN |
| SECONDARY | Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8 | Baseline, Week 8 | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | nanogram per liter (ng/L) | MEDIAN |
| SECONDARY | Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8 | Week 8 | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Serum Phosphorus Level at Week 4 | Baseline, Week 4 | Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | mmol/L | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Event | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Analysis was performed on safety population that consisted of all randomized participants who received at least one dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Analysis was performed on safety population. Here, number analyzed = participants with available data for the specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Vital Signs Abnormalities | From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 | Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories. | Participants | COUNT_OF_PARTICIPANTS |
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/NCT03001011/outcomes