Clinical Trial Details
| Trial ID: | L1369 |
| Source ID: | NCT01922843 |
| Associated Drug: | Dp001 Softgel Capsules |
| Title: | A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis |
| Acronym: | 2MD-7H-2B |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Hyperparathyroidism, Secondary|Kidney Failure, Chronic |
| Interventions: | DRUG: DP001 softgel capsules|DRUG: Placebo |
| Outcome Measures: | Primary: The proportion of patients who achieve two consecutive > or = 30% decreases from his/her baseline serum iPTH level, 12 weeks, with weekly iPTH measurements | Secondary: Mean percentage change in serum iPTH, Baseline to 12 weeks |
| Sponsor/Collaborators: | Sponsor: Deltanoid Pharmaceuticals |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 62 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2013-09 |
| Completion Date: | 2014-06 |
| Results First Posted: | |
| Last Update Posted: | 2017-08-18 |
| Locations: | Phoenix, Arizona, United States|Tucson, Arizona, United States|Washington, D.C., District of Columbia, United States|Evanston, Illinois, United States|Saint Louis, Missouri, United States|Las Vegas, Nevada, United States|Great Neck, New York, United States|Ridgewood, New York, United States|Charlotte, North Carolina, United States|Cincinnati, Ohio, United States|Nashville, Tennessee, United States|Fort Worth, Texas, United States|Grand Prairie, Texas, United States|San Antonio, Texas, United States |
| URL: | https://clinicaltrials.gov/show/NCT01922843 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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