Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT01439867
Eligibility Criteria:
Inclusion criteria:
* Subjects between the ages of 28 days to \< 6 years of age at enrollment (Czech Republic minimum age is ≥ 2 years of age at enrollment)
* Screening plasma iPTH level \> 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing
* Screening corrected calcium from the central laboratory:
* ≥ 9.4 mg/dL (2.35 mmol/L) if age 28 days to \< 2 years
* ≥ 8.8 (2.2 mmol/L) if age ≥ 2 to \< 6 years
* Serum phosphorus from the central laboratory:
* ≥ 5.0 mg/dL (1.25 mmol/L) if age 28 days to \< 1 year
* ≥ 4.5 mg/dL (1.13 mmol/L) if age ≥ 1 to \< 6 years
* SHPT not due to vitamin D deficiency, per investigator assessment
* Dry weight ≥ 7 kg at the time of screening
Exclusion criterion:
* History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval
* Corrected QT interval (QTc) \> 500 ms, using Bazett's formula
* QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
* Use of grapefruit juice, herbal medications, or potent CYP 3A4 inhibitors (e.g., erythromycin, clarithromycin, ketoconazole, itraconazole)
* Use of concomitant medications that may prolong the QTc interval (e.g., ondansetron, albuterol)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Days
Maximum Age:
2189 Days
Study:
NCT01439867
Study Brief:
Protocol Section:
NCT01439867