Trial · NCT02781844
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose ; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | Pharmacokinetic (PK) analysis set consisted of all enrolled participants who did not have major protocol violations that affected the validity of the PK results, received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable postdose PK concentration value available for 1 dose regimen. | hours | MEDIAN |
| PRIMARY | Maximum Plasma Concentration (Cmax) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | picogram per milliliter (pg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific category. | hour*picogram per milliliter (h*pg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Curve Extrapolated to Infinity (AUCinf) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific category. | h*pg/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration Curve From Time Zero to 24 Hours Post the First Dose (AUC0-24) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | h*pg/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration Curve From Time Zero to 12 Hours Post the First Dose (AUC0-12) of Baseline Adjusted rhPTH(1-84) | BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | h*pg/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration Curve From Time of the Second Dose to 12 Hours Post the Second Dose (AUC12-24) of Baseline Adjusted rhPTH(1-84) | BID: 12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | h*pg/mL | GEOMETRIC_MEAN |
| PRIMARY | Terminal Half-Life (t1/2) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific category. | hours | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-Time Curve That is Above the Baseline, From Time 0 to 24 Hours (AUCabove) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Day -1 | Pharmacodynamic (PD) analysis set consisted of all enrolled participants who did not have major protocol violations that affected the validity of the PD results, received at least 1 dose of rhPTH(1 84) and had at least 1 evaluable post-dose PD value available for 1 dose regimen. | hour*millimoles per Liter (h*mmol/L) | MEAN |
| PRIMARY | Area Under the Concentration-Time Curve That is Below the Baseline, From Time 0 to 24 Hours (AUCbelow) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Day -1 | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | h*mmol/L | MEAN |
| PRIMARY | Time to Maximum Effect (TEmax) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Day -1 | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | hours | MEDIAN |
| PRIMARY | Maximum Effect (Emax) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Day -1 | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | millimoles/Liter (mmol/L) | MEAN |
| PRIMARY | Area Under the Concentration-Time Curve That is Above the Baseline, From Time 0 to 24 Hours (AUCabove) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2 | Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | h*mmol/L | MEAN |
| PRIMARY | Area Under the Concentration-Time Curve That is Below the Baseline, From Time 0 to 24 Hours (AUCbelow) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2 | Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | h*mmol/L | MEAN |
| PRIMARY | Time to Maximum Effect (TEmax) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2 | Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | hours | MEDIAN |
| PRIMARY | Maximum Effect (Emax) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2 | Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | mmol/L | MEAN |
| PRIMARY | Total Amount of Urinary Calcium Excretion to Total Relative Amount of Creatinine Over 24 Hours by Day -1 | Day -1 | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | mmol/mmol | MEAN |
| PRIMARY | Total Amount of Urinary Calcium Excretion to Total Relative Amount of Creatinine Over 24 Hours by Day 1/ Day 2 | Day 1- QD: Pre-dose up to 24 hours post dose, Day 2- BID: Pre-dose up to 24 hours post dose | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | millimoles Per millimoles (mmol/mmol) | MEAN |
| PRIMARY | Total Urinary Excretion of Calcium Over 24 Hours by Day -1 | Day -1 | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | mmol | MEAN |
| PRIMARY | Total Urinary Excretion of Calcium Over 24 Hours by Day 1/ Day 2 | Day 1- QD: Pre-dose up to 24 hours post dose, Day 2- BID: Pre-dose up to 24 hours post dose | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | mmol | MEAN |
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.
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