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Sponsors and Collaborators: |
University of Toledo Health Science Campus GlaxoSmithKline |
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Information provided by: | University of Toledo Health Science Campus |
ClinicalTrials.gov Identifier: | NCT00638222 |
Evaluate effectiveness of Carvedilol CR on Micro T-Wave Alternans in high risk hypertensives
Condition | Intervention |
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Vascular Disease Kidney Disease |
Drug: Carvedilol Drug: Placebo |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease |
Estimated Enrollment: | 30 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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IA: Active Comparator
Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
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Drug: Carvedilol
Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
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2A: Placebo Comparator
Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
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Drug: Placebo
Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
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The effect of Carvedilol CR on Micro T-Wave Alternans will be assessed in 30 hypertensives with stage 4 or 5 chronic kidney disease utilizing a cross-over design and contrasting no treatment against active treatment periods of 8 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary Ann Ankenbrandt, , RN | 419-383-6293 | Maryann.ankenbrandt@utoledo.edu |
Contact: Christopher Cooper, , MD | 419-383-3697 | christopher.cooper@utoledo.edu |
United States, Ohio | |
University of Toledo, Health Science Campus | Recruiting |
Toledo, Ohio, United States, 43606 | |
Contact: Christopher Cooper, MD 419-383-3697 christopher.cooper@utoledo.edu | |
United States, Rhode Island | |
Site Rhode Island Hospital | Recruiting |
Providence, Rhode Island, United States, 02903 | |
Contact: Lance Dworkin | |
Contact: Ann Marie O'Mara 401-444-8554 AOmara@Lifespan.org | |
Principal Investigator: Lance Dworkin, MD |
Principal Investigator: | Christopher Cooper, , MD | University of Toledo |
Responsible Party: | University of Toledo, Health Science Campus ( Christopher J Cooper, MD ) |
Study ID Numbers: | UTHSC-08 |
Study First Received: | March 5, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00638222 |
Health Authority: | United States: Institutional Review Board |
Carvedilol Heart Disease Vascular Disease Kidney |
Renal Insufficiency Heart Diseases Urologic Diseases Renal Insufficiency, Chronic Vascular Diseases |
Kidney Failure, Chronic Kidney Diseases Carvedilol Kidney Failure |
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Adrenergic alpha-Antagonists |
Antihypertensive Agents Pharmacologic Actions Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists |