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Sponsors and Collaborators: |
Abbott Massachusetts General Hospital Harvard University |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00497146 |
To investigate the effects of paricalcitol capsules on changes on cardiac structure and function in subjects with Stage 3B/4 Chronic Kidney Disease who have left ventricular hypertrophy
Condition | Intervention | Phase |
---|---|---|
Chronic Kidney Disease Left Ventricular Hypertrophy |
Drug: paricalcitol Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | The PRIMO Study-Paricalcitol Capsules Benefits in Renal Failure Induced Cardiac Morbidity in Chronic Kidney Disease Stage 3B/4 |
Estimated Enrollment: | 220 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: paricalcitol
2 mcg capsule
|
2: Placebo Comparator |
Drug: placebo
placebo capsule
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Echocardiogram results of:
Exclusion Criteria:
Subject has clinically significant coronary artery disease (CAD) within the previous 3 months, defined as one of the following:
Subject has major cardiac valve abnormality linked with LVH and/or diastolic dysfunction, defined as one of the following:
Contact: Anne Kavanaugh | 1-847-938-1722 | anne.kavanaugh@abbott.com |
Contact: Dennis Andress, MD | 1-847-936-3555 | dennis.andress@abbott.com |
Principal Investigator: | Ravi Thadhani, MD, MPH | Massachusetts General Hospital, Harvard Medical School |
Responsible Party: | Abbott ( Dennis Andress, MD ) |
Study ID Numbers: | M10-030, EudraCT 2007-001689-34 |
Study First Received: | July 3, 2007 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00497146 |
Health Authority: | United States: Food and Drug Administration |
Chronic Kidney Disease (CKD) Left Ventricular Hypertrophy (LVH) Zemplar |
paricalcitol PRIMO Chronic Kidney Disease Stage 3B/4 |
Pathological Conditions, Anatomical Hypertrophy, Left Ventricular Renal Insufficiency Heart Diseases Kidney Failure, Chronic Ergocalciferols Hypertrophy |
Vitamin D Urologic Diseases Renal Insufficiency, Chronic Kidney Diseases Cardiomegaly Kidney Failure |
Growth Substances Vitamins Physiological Effects of Drugs Bone Density Conservation Agents |
Cardiovascular Diseases Micronutrients Pharmacologic Actions |