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

NCT00537043 | Completed Phase 1

• 1 other identifier: CFD110733
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hypertension

Keywords

hypertension,; carvedilol,; repeat-dosing

Outcome Measures

Primary Outcomes (1)

• Comparison of the amount of SB-568859 found in the blood after a 7 days of dosing with carvedilol controlled release and carvedilol controlled release plus lisinopril

  7 days

Secondary Outcomes (3)

• Assessment of the safety and tolerability of carvedilol controlled release and the fixed dose combination based on blood and urine tests, vital signs, and reporting of side effects.

  7 days

• The pharmacokinetic parameters to be evaluated are the Tmax, Ct, and t1/2 of carvedilol [R(+)- and S(-)-enantiomers] when administered as the FDC formulation compared to COREG CR alone.

• Safety and tolerability as assessed by clinical data from AE reporting, nurse/physician observations, vital signs, ECGs and safety laboratory tests.

Interventions

SK&F-105517 (COREG CR FDC) DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 \[Note: combination antihypertensive and/or diuretic products (such as lisinopril and hydrochlorothiazide) should be considered as 2 medications, and the doses of each component should be recorded.\]
• Subjects who metabolize carvedilol poorly based on CYP2D6 genotyping as determined at screening
• History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening
• Positive urine drug screen (UDS) including alcohol at screening. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
• Treatment with an investigational drug within 30 days or five half-lives, whichever is longer, prior to the first dose of study medication (this includes investigational formulations of marketed products)
• Subjects receiving ongoing treatment or anticipated to receive treatment with any of the following medications during treatment with study medication:

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Hackensack, New Jersey, 07601, United States

Location

GSK Investigational Site

Austin, Texas, 78704, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: September 28, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: October 19, 2010

Record last verified: 2010-10

Locations

US (2)