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NCT00664430
Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects
Phase 4 trial testing Calcitriol in Secondary Hyperparathyroidism in 13 participants. Terminated before completion.
1 June 2009
Quick facts
| Lead sponsor | Abbott |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 1 January 2009 |
| Primary completion | 1 June 2009 |
| Estimated completion | 1 June 2009 |
| Sites | 2 locations across Brazil |
Drugs / interventions tested
- Calcitriol (CALCITRIOL) — full drug profile →
- Paricalcitol (PARICALCITOL) — full drug profile →
Conditions studied
- Secondary Hyperparathyroidism — all drugs for Secondary Hyperparathyroidism →
- Dialysis — all drugs for Dialysis →
Sponsor
Abbott — full company profile →
Who can join
18 and older, any sex, with Secondary Hyperparathyroidism or Dialysis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Proportion of Participants With a 50% Reduction in Parathyroid Hormone (PTH) Levels Relative to Visit 4 Values
Time frame: Up to Week 24
This outcome was measured at Visit 15, which could occur at different timepoints from study start, depending on the duration of each study period for each participant, relative to values on Visit 4. For participants who did not perform visit 4, the reduction of the PTH levels were to be assessed relative to visit 5 values.
Sponsor's own description
The primary objective of this study is to evaluate the efficacy and safety of paricalcitol in participants with moderate to severe secondary hyperparathyroidism (SHPT) undergoing hemodialysis who are resistant to treatment with calcitriol.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00664430
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Secondary Hyperparathyroidism
Currently open trials in the same condition.
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- NCT03969329 — A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis · Phase 3 · recruiting
- NCT03633708 — A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemo · Phase 3 · recruiting
Other Abbott trials
Trials by the same sponsor.
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- NCT04784208 — A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY) · unknown
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00664430 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Abbott
- Last refreshed: 18 January 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00664430.
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