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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00556920 |
Purpose
This study will be a randomized study investigating the bioequivalence of COREG CR and Lisinopril to COREG CR and ZESTRIL
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: COREG CR |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-label, Single-dose, Three-period, Crossover Study to Demonstrate the Bioequivalence of the Fixed Dose Combination (FDC) of COREG CR™ and Lisinopril to COREG CR and ZESTRIL |
| Enrollment: | 50 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00556920 History of Changes |
| Other Study ID Numbers: | CFD106094 |
| Study First Received: | November 9, 2007 |
| Last Updated: | October 13, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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Coreg CR |
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Hypertension Vascular Diseases Cardiovascular Diseases Carvedilol Lisinopril Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Cardiotonic Agents Protective Agents |