| Outcome Measures: |
Primary: Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase, The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used., From Baseline to the Efficacy Assessment Phase, Weeks 25-30 | Secondary: Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase, The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used., From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30|Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period, Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations: Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 - Serum albumin (g/dL)). The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.", From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase, The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used., From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase, The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used., From Baseline to end of Efficacy Assessment Period, assessed up to 30 weeks|Growth Velocity From Baseline to End of Double-blind Phase, Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of double-blind phase visit was at Week 30 by design but the last assessment in the double-blind phase was used due to the early termination of the study., From Baseline to end of Efficacy Assessment at Week 30|Growth Velocity From End of Double-blind Phase to End of Open-label Phase, Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of open-label phase visit was at Week 60 by design but the last assessment in the open-label phase was used due to the early termination of the study., End of double-blind phase (Week 30) until end of the open-label phase (Week 60)|Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase, The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used., From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
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| Locations: |
Research Site, Birmingham, Alabama, 35233, United States|Research Site, Los Angeles, California, 90095, United States|Research Site, San Francisco, California, 94143, United States|Research Site, Gainesville, Florida, 32610, United States|Research Site, Baltimore, Maryland, 21287, United States|Research Site, Boston, Massachusetts, 02115, United States|Research Site, Kansas City, Missouri, 64108, United States|Research Site, Saint Louis, Missouri, 63104, United States|Research Site, Saint Louis, Missouri, 63110, United States|Research Site, Livingston, New Jersey, 07039, United States|Research Site, Bronx, New York, 10467, United States|Research Site, Greenville, North Carolina, 27834, United States|Research Site, Cincinnati, Ohio, 45229, United States|Research Site, Portland, Oregon, 97227, United States|Research Site, Philadelphia, Pennsylvania, 19104, United States|Research Site, Houston, Texas, 77030, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Charlottesville, Virginia, 22908, United States|Research Site, Randwick, New South Wales, 2031, Australia|Research Site, Westmead, New South Wales, 2145, Australia|Research Site, Herston, Queensland, 4029, Australia|Research Site, Parkville, Victoria, 3052, Australia|Research Site, Bruxelles, 1020, Belgium|Research Site, Edegem, 2650, Belgium|Research Site, Gent, 9000, Belgium|Research Site, Leuven, 3000, Belgium|Research Site, Heidelberg, 69120, Germany|Research Site, Marburg, 35043, Germany|Research Site, Budapest, 1083, Hungary|Research Site, Debrecen, 4032, Hungary|Research Site, Pecs, 7623, Hungary|Research Site, Szeged, 6720, Hungary|Research Site, Mexico, Distrito Federal, 04530, Mexico|Research Site, Aguascalientes, 20219, Mexico|Research Site, Gdansk, 80-952, Poland|Research Site, Gorzow Wielkopolski, 66-400, Poland|Research Site, Lodz, 93-338, Poland|Research Site, Warszawa, 00-576, Poland|Research Site, Warszawa, 04-730, Poland|Research Site, Moscow, 107014, Russian Federation|Research Site, Saint Petersburg, 198205, Russian Federation|Research Site, Samara, 443095, Russian Federation|Research Site, Banska Bystrica, 974 09, Slovakia|Research Site, Bratislava, 833 40, Slovakia|Research Site, Kosice, 040 11, Slovakia|Research Site, Barcelona, Cataluña, 08035, Spain|Research Site, Barcelona, Cataluña, 08035, Spain|Research Site, Valencia, Comunidad Valenciana, 46026, Spain|Research Site, Baracaldo, PaÃ-s Vasco, 48903, Spain|Research Site, Baracaldo, País Vasco, 48903, Spain|Research Site, Madrid, 28046, Spain
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