A Phase 2/3 interventional study of Calcifediol 75mcg and Calcifediol 100mcg in Vitamin D Deficiency and Vitamin D Insufficiency, sponsored by Faes Farma, S.A.. Completed at 55 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Faes Farma, S.A. · Phase 2/3, Interventional, and Treatment
This is a randomised, double-blind, double-dummy, multicentre, dose-ranging clinical trial in subjects with vitamin D deficiency or insufficiency. Its general objective is to determine the efficacy and safety of different doses of calcifediol soft gelatin capsules (SGCs) compared to placebo.
Exclusion Criteria:
Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Other: Placebo
Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Drug: Calcifediol 75mcg · Other: Placebo
Subjects corresponding to Cohort 1 (25-OH-D baseline level \> 10 to \< 20 ng/mL)
Drug: Calcifediol 100mcg · Other: Placebo
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Other: Placebo
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Drug: Calcifediol 100mcg · Other: Placebo
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
Drug: Calcifediol 125mcg · Other: Placebo
Soft gelatin capsule. Oral administration once per week
Soft gelatin capsule. Oral administration once per week
Soft gelatin capsule. Oral administration once per week.
Soft gelatin capsule. Oral administration once per week.
Soft gelatin capsule. Oral administration once per week.
To assess efficacy for each cohort in terms of percentage of subjects achieving 25-OH-D levels ≥ 30 ng/mL and/or ≥ 20 ng/mL at 16 weeks of treatment.
Percentage of subjects who achieve 25-OH-D levels ≥ 30 ng/mL and/or ≥ 20 ng/mL
Time frame: 16 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Faes Farma, S.A.