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Cytochroma launches phase IIb of CTAP101 capsules
March 1, 2011
Pharmaceutical company Cytochroma announced a repeat-dose safety and efficacy study of CTAP101 capsules in patients with vitamin D insufficiency, secondary hyperparathyroidism and stage III chronic kidney disease.
The trial is a randomized, double-blind, placebo-controlled, multi-site study evaluating the safety, efficacy, pharmacokinetics, pharmacodynamics and tolerability of CTAP101 capsules, administered at daily doses, in 60 patients. Study endpoints will include vitamin D status, adverse events, physical and clinical laboratory assessments and changes in serum calcium, phosphorus and intact parathyroid hormone.
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