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Clinical Trial Details

Trial ID:	L0925
Source ID:	NCT00497146
Associated Drug:	Paricalcitol
Title:	The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4
Acronym:	PRIMO
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT00497146/results
Conditions:	Chronic Kidney Disease\|Left Ventricular Hypertrophy
Interventions:	DRUG: paricalcitol\|DRUG: placebo
Outcome Measures:	Primary: Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI), The Central Cardiac MRI Core Laboratory (CCL) interpreted and analyzed all cardiac MRI data. Left Ventricular Mass (LVM) was normalized to the participant's height by the following equation to obtain LVMI: LVM (grams) divided by height (meters)\^2.7., Baseline to 48 weeks \| Secondary: Change in Diastolic Mitral Annular Relaxation Velocity (E'), Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function., Baseline to 48 weeks\|Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E'), The ratio of peak E wave velocity to lateral E wave velocity (E/E') is a measure of diastolic function., Baseline to 48 weeks\|Change in E-wave Deceleration Time (DT), E-wave deceleration time (DT) is a measure of diastolic function., Baseline to 48 weeks\|Change in Isovolumetric Relaxation Time (IVRT), Isovolumetric relaxation time (IVRT) is a measure of diastolic function., Baseline to 48 weeks\|Change in Left Atrial Volume, Left atrial volume is a measure of diastolic function., Baseline to 48 weeks\|Change in Plasma Triiodothyronine (T3), Plasma triiodothyronine (T3) is a biological and inflammatory marker., Baseline to 48 weeks\|Change in Interleukin-6 (IL-6), Interleukin-6 (IL-6) is a biological and inflammatory marker., Baseline to 48 weeks\|Change in Troponin-T, Troponin-T is a biological and inflammatory marker., Baseline to 48 weeks\|Change in B-type Natriuretic Peptide (BNP), B-type natriuretic peptide (BNP) is a biological and inflammatory marker., Baseline to 48 weeks\|Change in High Sensitivity C-reactive Protein (hsCRP), High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker., Baseline to 48 weeks\|Change in Progression of Thoraco-abdominal Aortic Plaque Volume, Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume., Baseline to 48 weeks\|Change in Progression of Thoraco-abdominal Aortic Wall Volume, Change from baseline to Week 48 in thoraco-abdominal aortic wall volume, Baseline to 48 weeks\|Change in Progression of Aortic Compliance, Change from baseline to Week 48 in aortic compliance., Baseline to 48 weeks\|Change in Progression of Left Ventricular End-systolic Volume Index, Change from baseline to Week 48 in left ventricular end-systolic volume index., Baseline to 48 weeks\|Change in Progression of Left Ventricular End-diastolic Volume Index, Change from baseline to Week 48 in left ventricular end-diastolic volume index., Baseline to 48 weeks\|Change in Progression of Left Ventricular Ejection Fraction, Change from baseline to Week 48 in left ventricular ejection fraction., Baseline to 48 weeks
Sponsor/Collaborators:	Sponsor: AbbVie (prior sponsor, Abbott) \| Collaborators: Massachusetts General Hospital
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	227
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date:	2008-02
Completion Date:	2012-03
Results First Posted:	2011-12-23
Last Update Posted:	2013-03-12
Locations:	Site Reference ID/Investigator# 8062, Phoenix, Arizona, 85012, United States\|Site Reference ID/Investigator# 8867, Tempe, Arizona, 85284, United States\|Site Reference ID/Investigator# 8864, San Diego, California, 92123, United States\|Site Reference ID/Investigator# 7257, San Dimas, California, 91773, United States\|Site Reference ID/Investigator# 7727, Denver, Colorado, 80230, United States\|Site Reference ID/Investigator# 8861, Miami, Florida, 33136, United States\|Site Reference ID/Investigator# 7260, Orlando, Florida, 32806, United States\|Site Reference ID/Investigator# 7725, Tampa, Florida, 33603, United States\|Site Reference ID/Investigator# 7824, Tampa, Florida, 33614, United States\|Site Reference ID/Investigator# 18882, Meridian, Idaho, 83642, United States\|Site Reference ID/Investigator# 7823, Chicago, Illinois, 60617, United States\|Site Reference ID/Investigator# 7249, Evergreen Park, Illinois, 60805, United States\|Site Reference ID/Investigator# 7816, Bethesda, Maryland, 20814, United States\|Site Reference ID/Investigator# 18881, Rockville, Maryland, 20852, United States\|Site Reference ID/Investigator# 7817, Springfield, Massachusetts, 01107, United States\|Site Reference ID/Investigator# 7245, Detroit, Michigan, 48202, United States\|Site Reference ID/Investigator# 7248, Royal Oak, Michigan, 48073, United States\|Site Reference ID/Investigator# 8868, Kansas City, Missouri, 64128, United States\|Site Reference ID/Investigator# 7828, St. Louis, Missouri, 63110, United States\|Site Reference ID/Investigator# 14442, Omaha, Nebraska, 68131-3403, United States\|Site Reference ID/Investigator# 6567, Winston-Salem, North Carolina, 27103, United States\|Site Reference ID/Investigator# 7262, Winston-Salem, North Carolina, 27157-1045, United States\|Site Reference ID/Investigator# 7826, Allentown, Pennsylvania, 18103, United States\|Site Reference ID/Investigator# 8865, Chattanooga, Tennessee, 37404, United States\|Site Reference ID/Investigator# 7261, Houston, Texas, 77004, United States\|Site Reference ID/Investigator# 8058, Houston, Texas, 77099, United States\|Site Reference ID/Investigator# 7830, San Antonio, Texas, 78229, United States\|Site Reference ID/Investigator# 7825, Murray, Utah, 84157-7000, United States\|Site Reference ID/Investigator# 8866, Provo, Utah, 84604, United States\|Site Reference ID/Investigator# 7263, Fairfax, Virginia, 22033, United States\|Site Reference ID/Investigator# 8493, Adelaide, 5000, Australia\|Site Reference ID/Investigator# 8506, Liverpool, 2170, Australia\|Site Reference ID/Investigator# 8507, Parkville, 3050, Australia\|Site Reference ID/Investigator# 9581, Reservoir, 3073, Australia\|Site Reference ID/Investigator# 9582, Richmond, 3121, Australia\|Site Reference ID/Investigator# 8500, Westmead, 2145, Australia\|Site Reference ID/Investigator# 8246, Prague 4, 14021, Czech Republic\|Site Reference ID/Investigator# 8499, Prague 6, 16900, Czech Republic\|Site Reference ID/Investigator# 8245, Prague, 12808, Czech Republic\|Site Reference ID/Investigator# 6692, Dortmund, 44263, Germany\|Site Reference ID/Investigator# 9723, Duesseldorf, 40210, Germany\|Site Reference ID/Investigator# 6630, Luebeck, 23538, Germany\|Site Reference ID/Investigator# 7268, Nettetal, 41334, Germany\|Site Reference ID/Investigator# 6622, Wuerzburg, 97080, Germany\|Site Reference ID/Investigator# 10626, Lido di Camaiore, 55041, Italy\|Site Reference ID/Investigator# 8070, Naples, 80131, Italy\|Site Reference ID/Investigator# 8060, Rome, 00165, Italy\|Site Reference ID/Investigator# 8519, Lodz, 90-153, Poland\|Site Reference ID/Investigator# 7702, Humacao, 00791, Puerto Rico\|Site Reference ID/Investigator# 7269, Ponce, 00717-1322, Puerto Rico\|Site Reference ID/Investigator# 7818, Rio Piedras, 00935, Puerto Rico\|Site Reference ID/Investigator# 7270, San Juan, 00909, Puerto Rico\|Site Reference ID/Investigator# 7712, San Juan, 00918, Puerto Rico\|Site Reference ID/Investigator# 7266, Toa Baja, 00949, Puerto Rico\|Site Reference ID/Investigator# 8881, Bucharest, 010731, Romania\|Site Reference ID/Investigator# 8518, Bucharest, 022328, Romania\|Site Reference ID/Investigator# 8514, Iasi, 700503, Romania\|Site Reference ID/Investigator# 22682, Moscow, 105229, Russian Federation\|Site Reference ID/Investigator# 8009, Moscow, 123182, Russian Federation\|Site Reference ID/Investigator# 7251, Moscow, 125284, Russian Federation\|Site Reference ID/Investigator# 7250, Moscow, 127473, Russian Federation\|Site Reference ID/Investigator# 8883, Barcelona, 08003, Spain\|Site Reference ID/Investigator# 8358, Barcelona, 08035, Spain\|Site Reference ID/Investigator# 8355, Madrid, 28007, Spain\|Site Reference ID/Investigator# 8356, Madrid, 28041, Spain\|Site Reference ID/Investigator# 8882, Santander (Cantabria), 39008, Spain\|Site Reference ID/Investigator# 8234, Hsin-Chuang City, Taiwan\|Site Reference ID/Investigator# 8884, Taipei, 10002, Taiwan\|Site Reference ID/Investigator# 8228, Taipei, Taiwan\|Site Reference ID/Investigator# 8229, Taoyuan, Taiwan\|Site Reference ID/Investigator# 8823, Coventry, CV2 2DX, United Kingdom
URL:	https://clinicaltrials.gov/show/NCT00497146

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Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress

Clinical Trial Details

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Associated NAFLD Drugs (0)