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NCT01000961 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With Cystinosis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 43
- Enrollment target
NCT01000961 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 43 participants.
The verdict
NCT01000961, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 43 participants
- Enrollment target
Study Summary
Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being studied to see if it may be able to be given less frequently, once every 12 hours, and have similar results to four times a day Cystagon®.
Interventions
- DRUG Cystagon® (Cysteamine Bitartrate)
- DRUG Cysteamine Bitartrate Delayed-release Capsules (RP103)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01000961
The ClinicalTrials.gov registry entry for NCT01000961 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cystagon® (Cysteamine Bitartrate) is the first listed.
NCT01000961 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01000961 about?
NCT01000961 is a clinical study titled "Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With Cystinosis". Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP103...
What is the current status of trial NCT01000961?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 43 participants. The study started on 2010-06. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01000961?
The interventions under investigation include: Cystagon® (Cysteamine Bitartrate) (DRUG), Cysteamine Bitartrate Delayed-release Capsules (RP103) (DRUG).
Who is sponsoring clinical trial NCT01000961?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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