Trials / Completed
CompletedNCT00527085
12-month Study of AMG 073 in Renal Osteodystrophy
A Multicenter, Randomized, Placebo-controlled, Double-blind, 12-month Study to Assess the Effects of an Oral Calcimimetic Agent (AMG 073) on Renal Osteodystrophy in Hemodialysis Patients With Secondary Hyperparathyroidism
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 073 | 30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally |
| DRUG | Placebo | 30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally |
Timeline
- Start date
- 2001-10-01
- Primary completion
- 2003-08-01
- Completion
- 2003-08-01
- First posted
- 2007-09-10
- Last updated
- 2013-05-08
Source: ClinicalTrials.gov record NCT00527085. Inclusion in this directory is not an endorsement.