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COMPLETEDPHASE1

A Study to Compare COREG CR to COREG CR Fixed-dose Combination in Patients With High Blood Pressure

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

NCT00537043•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult males or females of non-child bearing potential who are between 18 and 60 years old.
•Have a history of mild to moderate essential hypertension or present with mild to moderate essential hypertension defined by Diastolic Blood Pressure \>/90 and \</109 mmHg, and/or Systolic Blood Pressure \>/140 and \</179 mmHg
•Body weight \> 60 kg (132 pounds) and body mass index (BMI) between 19 and 35

Exclusion Criteria

•Any clinically relevant abnormality identified on the screening history, physical or laboratory examination, or any other medical condition or circumstances making the volunteer unsuitable for participation in the study.
•History of advanced retinopathy (i.e., Keith-Wagener Grade III or IV)
•Secondary forms of hypertension including (but not limited to) coarctation of the aorta, primary aldosteronism, renal artery stenosis, or pheochromocytoma
•Type 1 diabetics \[note: Type 2 diabetics with HgbA1c less than or equal to 9.0% can be enrolled provided the Investigator considers the subject clinically stable\]
•Signs, symptoms, or history of congestive heart failure, angina pectoris, myocardial infarction, cerebrovascular accident, or transient ischemic attacks
•History or presence of clinically significant hepatic disease
•Liver function tests (ALT, AST, total bilirubin or alkaline phosphatase) more than 2 times the upper limit of the laboratory reference range
•History of severe pulmonary disease including asthma or chronic obstructive lung disease or previous history of 'hypersensitivity' to B-blockers
•Previously treated hypertension in subjects in whom, at the discretion of the Investigator, antihypertensive therapy cannot be safely withdrawn during the study
•Subjects who are on more than 3 antihypertensive or diuretic medications \[Note: combination antihypertensive and/or diuretic products (such as lisinopril and hydrochlorothiazide) should be considered as 2 medications, and the doses of each component should be recorded.\]
+24 more criteria

Locations (2)

GSK Investigational Site

Hackensack, New Jersey, United States

GSK Investigational Site

Austin, Texas, United States

Key Dates

Start Date

October 1, 2007

Primary Completion Date

January 1, 2008

Completion Date

January 1, 2008

Last Updated

October 19, 2010

Enrollment

ESTIMATED participants

Conditions

Hypertension

Interventions

SK&F-105517 (COREG CR FDC)

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Compare COREG CR to COREG CR Fixed-dose Combination in Patients With High Blood Pressure

Inclusion Criteria

Exclusion Criteria

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