Outcome Measures: |
Primary: Percentage of Participants With Hypocalcemia, Hypocalcemia was defined as corrected serum calcium levels \< 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to \< 2 years, and \< 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to \< 6 years at any time during the study., 26 weeks | Secondary: Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study, 26 weeks|Percent Change From Baseline in Intact Parathyroid Hormone (iPTH), Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|Percent Change From Baseline in Corrected Serum Calcium, Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|Percent Change From Baseline in Serum Phosphorous, Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|Percent Change From Baseline in Calcium Phosphorus Product (Ca x P), Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements, A participant was considered to have achieved \> 30% reduction in iPTH from baseline at any 2 consecutive measurements if percent change of any two consecutive post-baseline iPTH values were \< -30% regardless if there was a missing value in between., 26 weeks|Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study, A participant was considered to have achieved ≥ 30% reduction in iPTH if the percent change of any post-baseline iPTH value was ≤ -30% from baseline., 26 weeks|Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements, A participant was considered to have achieved iPTH between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any 2 consecutive measurements if any two consecutive post-baseline iPTH values were within the range regardless if there was a missing value in between. The analysis included all enrolled subjects with at least 1 post-baseline assessment., 26 weeks|Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study, A participant was considered to have achieved iPTH \< 300 pg/mL (31.8 pmol/L) during the study if any post-baseline iPTH value was \< 300 pg/mL., 26 weeks|Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet, Week 12|Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet, Week 12
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Locations: |
Research Site, Birmingham, Alabama, 35233, United States|Research Site, Little Rock, Arkansas, 72202, United States|Research Site, Los Angeles, California, 90095, United States|Research Site, Iowa City, Iowa, 52242, United States|Research Site, Louisville, Kentucky, 40202, United States|Research Site, Baltimore, Maryland, 21287, United States|Research Site, Ann Arbor, Michigan, 48109, United States|Research Site, Kansas City, Missouri, 64108, United States|Research Site, Saint Louis, Missouri, 63110, 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, Oklahoma City, Oklahoma, 73104, United States|Research Site, Philadelphia, Pennsylvania, 19104, United States|Research Site, Dallas, Texas, 75390, United States|Research Site, Houston, Texas, 77030, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Bruxelles, 1020, Belgium|Research Site, Gent, 9000, Belgium|Research Site, Leuven, 3000, Belgium|Research Site, Praha 5, 150 06, Czechia|Research Site, Bron cedex, 69677, France|Research Site, Lille, 59800, France|Research Site, Paris, 75012, France|Research Site, Paris, 75015, France|Research Site, Paris, 75019, France|Research Site, Heidelberg, 69120, Germany|Research Site, Budapest, 1083, Hungary|Research Site, Debrecen, 4032, Hungary|Research Site, Szeged, 6720, Hungary|Research Site, Genova, 16147, Italy|Research Site, Roma, 00165, Italy|Research Site, Torino, 10126, Italy|Research Site, Chihuahua, 31000, Mexico|Research Site, Amsterdam, 1105 AZ, Netherlands|Research Site, Grafton, Auckland, 1023, New Zealand|Research Site, Gdansk, 80-952, Poland|Research Site, Krakow, 30-663, Poland|Research Site, Warszawa, 00-576, Poland|Research Site, Moscow, 107014, Russian Federation|Research Site, Saint Petersburg, 198205, Russian Federation|Research Site, Kosice, 040 11, Slovakia
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