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Clinical Trial Details

Trial ID: L0223
Source ID: NCT01071070
Associated Drug: Paricalcitol
Title: Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01071070/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: paricalcitol
Outcome Measures: Primary: The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels, The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values, Baseline to 12 Weeks | Secondary: The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL, The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL, Baseline to 12 Weeks|The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value, Baseline to 12 Weeks|The Change From Baseline to the Final Observation in Calcium, Baseline to 12 Weeks|The Change From Baseline to the Final Observation in Calcium-phosphorus Product, Baseline to 12 Weeks|The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure, Baseline to 12 Weeks|The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure, Baseline to 12 Weeks|The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate, Baseline to 12 Weeks|The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L), The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L), Baseline to 12 weeks
Sponsor/Collaborators: Sponsor: Abbott
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 216
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2009-11
Completion Date: 2010-11
Results First Posted: 2012-01-26
Last Update Posted: 2012-01-26
Locations: Site Reference ID/Investigator# 23483, Beijing, 100034, China|Site Reference ID/Investigator# 23485, Beijing, 100044, China|Site Reference ID/Investigator# 23482, Beijing, 100730, China|Site Reference ID/Investigator# 23484, Dalian City, 116011, China|Site Reference ID/Investigator# 23486, Guangzhou City, 510080, China|Site Reference ID/Investigator# 23488, Nanjing, 210029, China|Site Reference ID/Investigator# 37722, Qingdao, 266003, China|Site Reference ID/Investigator# 23490, Shanghai, 200001, China|Site Reference ID/Investigator# 25502, Shanghai, 200001, China|Site Reference ID/Investigator# 23489, Shanghai, 200025, China|Site Reference ID/Investigator# 23487, Shanghai, 200092, China|Site Reference ID/Investigator# 35822, Wenzhou, 325000, China
URL: https://clinicaltrials.gov/show/NCT01071070

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress