Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00042432
First received: July 29, 2002
Last updated: May 9, 2013
Last verified: May 2013
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| Tracking Information | |||||
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| First Received Date ICMJE | July 29, 2002 | ||||
| Last Updated Date | May 9, 2013 | ||||
| Start Date ICMJE | June 2002 | ||||
| Primary Completion Date | March 2003 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase [ Time Frame: Efficacy assessment phase (weeks 12-18) ] [ Designated as safety issue: No ] Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00042432 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase [ Time Frame: Baseline, efficacy assessment phase (weeks 12-18) ] [ Designated as safety issue: No ] Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients | ||||
| Official Title ICMJE | A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients | ||||
| Brief Summary | This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: cinacalcet (AMG 073)
Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks. |
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| Study Arm (s) |
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| Publications * | Charytan C, Coburn JW, Chonchol M, Herman J, Lien YH, Liu W, Klassen PS, McCary LC, Pichette V. Cinacalcet hydrochloride is an effective treatment for secondary hyperparathyroidism in patients with CKD not receiving dialysis. Am J Kidney Dis. 2005 Jul;46(1):58-67. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 54 | ||||
| Completion Date | August 2003 | ||||
| Primary Completion Date | March 2003 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00042432 | ||||
| Other Study ID Numbers ICMJE | 20010239 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Global Development Leader, Amgen Inc. | ||||
| Study Sponsor ICMJE | Amgen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Amgen | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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