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HypertensionPhase 1NCT00537043

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

A Phase 1 study testing SK&F-105517 (COREG CR FDC) in people with Hypertension, run by GlaxoSmithKline at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hypertension
What is being tested?
SK&F-105517 (COREG CR FDC)
How many people
24 participants
Where
2 sitesUnited States
Study dates
Oct 2007to Jan 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 34Show fewer
  • 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:
  • monoamine oxidase (MAO) inhibitors
  • any Class I or III antiarrhythmic
  • alpha-adrenergic receptor blockers
  • beta-2-adrenergic receptor agonists
  • lithium
  • Consumption of grapefruit or grapefruit juice within 7 days prior to dosing
  • Women of child-bearing potential
  • NOTE: Pre-menopausal females with a documented tubal ligation or hysterectomy are eligible. Postmenopausal females are eligible, defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory].
  • Resting pulse rate of ≤ 50 beats per minute (bpm) at screening
  • QTc ≥ 450 msec
  • ECG criteria as defined in protocol
  • Refusal or inability to discontinue use of medications known to be inhibitors/inducers of cytochrome P-450 2C9, 2D6 and 3A4 for at least 14 days or 5 half-lives [which ever is longer] prior to Day 1 of Session 1 and until 48 hours after the last dose of study medication. [Examples include: paroxetine, isoniazid, "azole"antifungal drugs (e.g. itraconazole), erythromycin, ticlopidine, amiodarone, quinidine, rifampin, phenobarbital]
  • Donation of blood in excess of 500 mL within a 56-day period including the estimated 210 mL of blood to be drawn during this study
  • History of sensitivity to carvedilol, lisinopril, alpha-blockers, beta-blockers or ACE inhibitors
  • History of sensitivity to heparin, heparin-induced thrombocytopenia, or sensitivity to any of the study medications or components thereof
  • History of angioedema
  • Positive for Hepatitis B surface antigen
  • Positive for HIV
  • Unwillingness or inability to follow the procedures outlined in the protocol or inability to provide written informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • GSK Investigational Site

    Austin, Texas, 78704

  • GSK Investigational Site

    Hackensack, New Jersey, 07601

Other trials in United States

About this 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

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
Being tested
SK&F-105517 (COREG CR FDC)
Keywords
hypertension,, carvedilol,, repeat-dosing
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SK&F-105517 (COREG CR FDC)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 7 days

Secondary outcomes (3)

  1. 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.

    Measured: 7 days

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00537043
Sponsor's protocol ID
CFD110733
Status last verified
Oct 2010
First submitted
27 Sep 2007
Last updated
19 Oct 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SK&F-105517 (COREG CR FDC) in people with Hypertension, run by GlaxoSmithKline at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00537043.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2010.

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Clinical Trial NCT00537043 | AzTrials