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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00537043 |
Carvedilol controlled release is a marketed drug to treat high blood pressure. This study is to compare carvedilol controlled release to carvedilol controlled release plus lisinopril (fixed-dose combination) after repeat dosing in patients with high blood pressure. This is to make sure that when carvedilol controlled release is given with lisinopril it acts the same in the body as when given alone. The study will also assess the safety and tolerability of the fixed-dose combination.
Condition | Intervention | Phase |
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Hypertension |
Drug: SK&F-105517 (COREG CR FDC) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, Randomized, Crossover, Repeat-Dose Study to Evaluate the Steady-State Pharmacokinetic Profile of the Final Fixed Dose Combination (FDC) Formulation of COREG CR and Lisinopril as Compared to COREG CR in Subjects With Essential Hypertension |
Estimated Enrollment: | 24 |
Study Start Date: | October 2007 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Subjects receiving ongoing treatment or anticipated to receive treatment with any of the following medications during treatment with study medication:
United States, New Jersey | |
GSK Investigational Site | |
Hackensack, New Jersey, United States, 07601 | |
United States, Texas | |
GSK Investigational Site | |
Austin, Texas, United States, 78704 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CFD110733 |
Study First Received: | September 27, 2007 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00537043 History of Changes |
Health Authority: | United States: Food and Drug Administration |
hypertension, carvedilol, repeat-dosing |
Essential Hypertension Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Lisinopril Vascular Diseases Cardiovascular Agents |
Adrenergic alpha-Antagonists Antihypertensive Agents Adrenergic beta-Antagonists Adrenergic Antagonists Hypertension Carvedilol |
Vasodilator Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vascular Diseases Adrenergic alpha-Antagonists Cardiovascular Agents |
Antihypertensive Agents Pharmacologic Actions Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Hypertension Carvedilol |