Trial · NCT01455181
A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary
NCT01455181, Phase 3, Completed, Shire; results first posted 2015-03-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary. Trials, record NCT01455181. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01455181
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary
- NCT number
- NCT01455181
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 24 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hypoparathyroidism
- Interventions
- NPSP558
- First posted
- 2011-10-19
- Last updated
- 2021-06-11
- Other registries' IDs
- eudract:2011-001265-40
- Results first posted
- 2015-03-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data. | 24 Weeks | A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory. |
| Secondary | Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit | 24 Weeks | |
| Secondary | Mean Percentage Changes From Baseline in Oral Calcium at Each Visit | 24 Weeks | |
| Secondary | Proportion of Patients Achieving the Primary Endpoint at Each Visit | 24 Weeks | A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory. |
| Secondary | Mean Change From Baseline in 24-hour Urine Calcium Excretion | 24 Weeks |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data. | 24 Weeks | percentage of participants | NUMBER | |
| SECONDARY | Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit | 24 Weeks | percentage of change | MEAN | |
| SECONDARY | Mean Percentage Changes From Baseline in Oral Calcium at Each Visit | 24 Weeks | The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement. | percentage of change | MEAN |
| SECONDARY | Proportion of Patients Achieving the Primary Endpoint at Each Visit | 24 Weeks | The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement . | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in 24-hour Urine Calcium Excretion | 24 Weeks | The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement. | mg/24 hour | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data. | NPSP558 | 75.0 | 95% Confidence Interval 53.3 to 90.2 | percentage of participants | |
| Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit | NPSP558 | Week 2 | -47.08 | Standard Deviation 31.566 | percentage of change |
| Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit | NPSP558 | Week 4 | -80.38 | Standard Deviation 16.688 | percentage of change |
| Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit | NPSP558 | Week 8 | -96.70 | Standard Deviation 7.865 | percentage of change |
| Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit | NPSP558 | Week 16 | -96.18 | Standard Deviation 11.521 | percentage of change |
| Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit | NPSP558 | Week 24 | -97.92 | Standard Deviation 10.206 | percentage of change |
| Mean Percentage Changes From Baseline in Oral Calcium at Each Visit | NPSP558 | Week 2 | -8.3 | Standard Deviation 36.20 | percentage of change |
| Mean Percentage Changes From Baseline in Oral Calcium at Each Visit | NPSP558 | Week 4 | -46.4 | Standard Deviation 35.57 | percentage of change |
| Mean Percentage Changes From Baseline in Oral Calcium at Each Visit | NPSP558 | Week 8 | -71.5 | Standard Deviation 33.14 | percentage of change |
| Mean Percentage Changes From Baseline in Oral Calcium at Each Visit | NPSP558 | Week 16 | -71.7 | Standard Deviation 38.60 | percentage of change |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NPSP558 | 24 | |
| Overall Study | COMPLETED | NPSP558 | 24 | |
| Overall Study | NOT COMPLETED | NPSP558 | 0 |
Source ClinicalTrials.gov
Adverse events17
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 | Hypoaesthesia | Nervous system disorders | NPSP558 | 12 | 24 | 23 |
| other | Headache | Nervous system disorders | NPSP558 | 4 | 24 | 5 |
| other | Paraesthesia | Nervous system disorders | NPSP558 | 2 | 24 | 3 |
| other | Hypercalcaemia | Metabolism and nutrition disorders | NPSP558 | 5 | 24 | 7 |
| other | Hypocalcaemia | Metabolism and nutrition disorders | NPSP558 | 4 | 24 | 4 |
| other | Tetany | Metabolism and nutrition disorders | NPSP558 | 3 | 24 | 3 |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | NPSP558 | 6 | 24 | 8 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | NPSP558 | 3 | 24 | 3 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | NPSP558 | 2 | 24 | 2 |
| other | Hypoaesthesia oral | Gastrointestinal disorders | NPSP558 | 3 | 24 | 4 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NPSP558 | ||
| Total, other adverse events | NPSP558 | 22 | 24 |
| Total, serious adverse events | NPSP558 | 0 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26684150 | RESULT |
Source PubMed
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/NCT01455181
GET https://conductscience.org/api/trials/v1/NCT01455181/registered