Trial · NCT02204579
A Study to Determine the Effects of NPSP795 on the Calcium-sensing Receptor in Subjects With Autosomal Dominant Hypocalcemia as Measured by PTH Levels and Blood Calcium Concentrations
NCT02204579, Phase 2, Completed, Shire; results first posted 2016-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Determine the Effects of NPSP795 on the Calcium-sensing Receptor in Subjects With Autosomal Dominant Hypocalcemia as Measured by PTH Levels and Blood Calcium Concentrations. Trials, record NCT02204579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02204579
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Determine the Effects of NPSP795 on the Calcium-sensing Receptor in Subjects With Autosomal Dominant Hypocalcemia as Measured by PTH Levels and Blood Calcium Concentrations
- NCT number
- NCT02204579
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Shire
- Conditions
- Autosomal Dominant Hypocalcemia (ADH)
- Interventions
- NPSP795
- First posted
- 2014-07-30
- Last updated
- 2021-08-09
- Results first posted
- 2016-12-21
Source ClinicalTrials.gov
Registered outcomes13
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 (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From Day 1 up to safety follow-up assessment (upto Day 17 after discharge) | |
| Primary | Number of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities | From Day 1 up to safety follow-up assessment (upto Day 17 after discharge) | |
| Primary | Number of Participants With Potentially Clinically Important Laboratory Abnormalities | From Day 1 up to safety follow-up assessment (upto Day 17 after discharge) | |
| Primary | Number of Participants With Clinically Significant Abnormalities Related to Physical Examination | From Day 1 up to safety follow-up assessment (upto Day 17 after discharge) | |
| Primary | Change From Baseline in Ionised Calcium | 10 Minute (min) Infusion Time: within 5 min pre-dose; & post-dose 15, 30, 45, 60, 75, 90, 105 min, and 2, 2.5, 3, 3.5, & 4 hour (hr) 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30, 45, 60, 75, 90, 105 min, & 2, 2.5, 3, 3.5, 4, 5, and 8 hr | |
| Primary | Change From Baseline in Serum Calcium | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hr. | |
| Primary | Change From Baseline in Urinary Calcium | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hr. | |
| Primary | Change From Baseline in Serum Parathyroid Hormone (PTH) | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr | |
| Secondary | Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795 | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr | |
| Secondary | Area Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP795 | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From Day 1 up to safety follow-up assessment (upto Day 17 after discharge) | Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment). | participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities | From Day 1 up to safety follow-up assessment (upto Day 17 after discharge) | Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants). | participants | NUMBER |
| PRIMARY | Number of Participants With Potentially Clinically Important Laboratory Abnormalities | From Day 1 up to safety follow-up assessment (upto Day 17 after discharge) | Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment). | participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities Related to Physical Examination | From Day 1 up to safety follow-up assessment (upto Day 17 after discharge) | Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants). | participants | NUMBER |
| PRIMARY | Change From Baseline in Ionised Calcium | 10 Minute (min) Infusion Time: within 5 min pre-dose; & post-dose 15, 30, 45, 60, 75, 90, 105 min, and 2, 2.5, 3, 3.5, & 4 hour (hr) 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30, 45, 60, 75, 90, 105 min, & 2, 2.5, 3, 3.5, 4, 5, and 8 hr | Post-amendment pharmacodynamic (PD) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively. | millimole/liter (mmol/L) | MEAN |
| PRIMARY | Change From Baseline in Serum Calcium | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hr. | Post-amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively. | millimole/liter (mmol/L) | MEAN |
| PRIMARY | Change From Baseline in Urinary Calcium | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hr. | PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively. | millimole/liter (mmol/L) | MEAN |
| PRIMARY | Change From Baseline in Serum Parathyroid Hormone (PTH) | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr | Post amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively. | nanogram/liter (ng/L) | MEAN |
| SECONDARY | Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795 | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr | Post amendment pharmacokinetic (PK) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion. | nanogram*hour per millilitre (ng·h/mL) | MEAN |
| SECONDARY | Area Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP795 | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr | Post amendment PK analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion. | nanogram*hour per milliliter(ng·h/mL) | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group85
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 (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | NPSP795 | Participants with TEAEs | 3 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | NPSP795 | Participants with TESAEs | 1 | participants | |
| Number of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities | NPSP795 | 0 | participants | ||
| Number of Participants With Potentially Clinically Important Laboratory Abnormalities | NPSP795 | 1 | participants | ||
| Number of Participants With Clinically Significant Abnormalities Related to Physical Examination | NPSP795 | 1 | participants | ||
| Change From Baseline in Ionised Calcium | NPSP795 on Day 1 (5 mg/10 Minutes) | Baseline | 0.972 | Standard Deviation 0.058 | millimole/liter (mmol/L) |
| Change From Baseline in Ionised Calcium | NPSP795 on Day 2 (15 mg/3.5 Hours) | Baseline | 0.950 | Standard Deviation 0.054 | millimole/liter (mmol/L) |
| Change From Baseline in Ionised Calcium | NPSP795 on Day 3 (30 mg/3.5 Hours) | Baseline | 0.986 | Standard Deviation 0.045 | millimole/liter (mmol/L) |
| Change From Baseline in Ionised Calcium | NPSP795 on Day 4 (30 mg/3.5 Hours) | Baseline | 0.933 | Standard Deviation 0.055 | millimole/liter (mmol/L) |
| Change From Baseline in Ionised Calcium | NPSP795 on Day 4 (50 mg/3.5 Hours) | Baseline | 1.025 | Standard Deviation 0.078 | millimole/liter (mmol/L) |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NPSP795 | 7 | |
| Overall Study | Participants Started in Pre-Amendment | NPSP795 | 2 | |
| Overall Study | Participants Started in Post-Amendment | NPSP795 | 5 | |
| Overall Study | Treated | NPSP795 | 5 | |
| Overall Study | COMPLETED | NPSP795 | 5 | |
| Overall Study | NOT COMPLETED | NPSP795 | 2 |
Source ClinicalTrials.gov
Adverse events4
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 | Cholelithiasis | Hepatobiliary disorders | NPSP795 | 1 | 5 | 1 |
| other | Hypersensitivity reaction | Immune system disorders | NPSP795 | 1 | 5 | 2 |
| other | Nipple pain | Reproductive system and breast disorders | NPSP795 | 1 | 5 | 1 |
| serious | Cholelithiasis | Hepatobiliary disorders | NPSP795 | 1 | 5 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NPSP795 | ||
| Total, other adverse events | NPSP795 | 3 | 5 |
| Total, serious adverse events | NPSP795 | 1 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02204579
GET https://conductscience.org/api/trials/v1/NCT02204579/results?page=2