Heart Failure, Congestive and MicroalbuminuriaPhase 3NCT00123903

COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria

A Phase 3 study testing metoprolol xl, carvedilol MR and lisinopril in people with Heart Failure, Congestive and Microalbuminuria, run by GlaxoSmithKline at 94 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study was designed to determine whether COREG MR is more effective than TOPROL-XL in reducing microalbuminuria in type 2 diabetic or non-diabetic patients with high blood pressure and microalbuminuria. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Heart Failure, Congestive and Microalbuminuria
What is being tested?: metoprolol xl, carvedilol MR and lisinopril
How many people: 1,220 participants
Where: 94 sitesin 3 countries
Study dates: Jul 2005to May 2006
Phase: Phase 3
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Documented history of hypertension.
Must have been taking an ACE (angiotensin converting enzyme) inhibitor either alone or as part of an antihypertensive regimen for at least 8 weeks.
Persistent microalbuminuria.

Who cannot join

History of heart attack, stroke, congestive heart failure, arrhythmia, type 1 or uncontrolled type 2 diabetes mellitus, liver or renal disease.
Has been taking any non-ocular beta-blockers for any indication within three months prior to Pre-screening.

Trial locations and contacts

94 sites in 3 countries.

Country

City, postcode or hospital

94 sites in 3 countries

United States72 sites

GSK Investigational Site
Avon, Indiana, 46123
GSK Investigational Site
Ayer, Massachusetts, 01432
GSK Investigational Site
Beaumont, Texas, 77701
GSK Investigational Site
Beaver, Pennsylvania, 15009
GSK Investigational Site
Birmingham, Alabama, 35213
GSK Investigational Site
Buffalo, New York, 14222
GSK Investigational Site
Burke, Virginia, 22015
GSK Investigational Site
Camillus, New York, 13031
GSK Investigational Site
Charlotte, North Carolina, 28211
GSK Investigational Site
Chicago, Illinois, 60607
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Cleveland, Ohio, 44130
GSK Investigational Site
Colorado Springs, Colorado, 80919
GSK Investigational Site
Columbus, Ohio, 43210-1296
GSK Investigational Site
Dallas, Texas, 75231
GSK Investigational Site
Dallas, Texas, 75390-9068
GSK Investigational Site
Decatur, Georgia, 30035
GSK Investigational Site
East Providence, Rhode Island, 02914
GSK Investigational Site
East Syracuse, New York, 13057
GSK Investigational Site
Edmonds, Washington, 98026
GSK Investigational Site
Elkhart, Indiana, 46515
GSK Investigational Site
Evansville, Indiana, 47713
GSK Investigational Site
Evansville, Indiana, 47714
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Fullerton, California, 92835
GSK Investigational Site
Galveston, Texas, 77555-0188
GSK Investigational Site
Greensboro, North Carolina, 27401
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Havertown, Pennsylvania, 19083
GSK Investigational Site
Hollywood, Florida, 33023
GSK Investigational Site
Houston, Texas, 77024
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Indianapolis, Indiana, 46250
GSK Investigational Site
Indianapolis, Indiana, 46254
GSK Investigational Site
Inglewood, California, 90301
GSK Investigational Site
Johnson City, Tennessee, 37604
GSK Investigational Site
Kettering, Ohio, 45429
GSK Investigational Site
Kingston, New York, 12401
GSK Investigational Site
Lafayette, Louisiana, 70503
GSK Investigational Site
Las Vegas, Nevada, 89119
GSK Investigational Site
Los Angeles, California, 90057
GSK Investigational Site
Melrose Park, Illinois, 60160
GSK Investigational Site
Miami, Florida, 33156
GSK Investigational Site
Miami, Florida, 33169
GSK Investigational Site
Midland, Texas, 79705
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
Mobile, Alabama, 36617
GSK Investigational Site
Oakland, California, 94609
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Olympia, Washington, 98502
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Oregon City, Oregon, 97045
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Philadelphia, Pennsylvania, 19152
GSK Investigational Site
Phoenix, Arizona, 85023
GSK Investigational Site
Port Chester, New York, 10573
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Reading, Pennsylvania, 19601
GSK Investigational Site
Redondo Beach, California, 90277
GSK Investigational Site
Rochester, New York, 14618
GSK Investigational Site
San Antonio, Texas, 78216
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Sarasota, Florida, 34239
GSK Investigational Site
Spokane, Washington, 99206
GSK Investigational Site
Spokane, Washington, 99207
GSK Investigational Site
Spokane, Washington, 99208
GSK Investigational Site
Springfield, Virginia, 22151
GSK Investigational Site
Tampa, Florida, 33614
GSK Investigational Site
Voorhees Township, New Jersey, 08043
GSK Investigational Site
Wenatchee, Washington, 98801
GSK Investigational Site
West Grove, Pennsylvania, 19390
GSK Investigational Site
Worcester, Massachusetts, 01608

Other trials in United States

Canada20 sites

GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, A0G 1G0
GSK Investigational Site
Bonaventure, Quebec, G0C 1E0
GSK Investigational Site
Brampton, Ontario, L6T 3J1
GSK Investigational Site
Calgary, Alberta, T2E 7C5
GSK Investigational Site
Charlottetown, Prince Edward Island, C1A 5Y9
GSK Investigational Site
Hamilton, Ontario, L8L 5G8
GSK Investigational Site
Kitchener, Ontario, N2G 1N9
GSK Investigational Site
London, Ontario, N5W 6A2
GSK Investigational Site
Mirabel, Quebec, J7J 2K8
GSK Investigational Site
Montague, Prince Edward Island, C0A 1R0
GSK Investigational Site
Montreal, Quebec, H2K 4L5
GSK Investigational Site
New Westminster, British Columbia, V3L 3W4
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3
GSK Investigational Site
Saint Romuald, Quebec, G6W 5M6
GSK Investigational Site
Stoney Creek, Ontario, L8G 2V6
GSK Investigational Site
Toronto, Ontario, M9W 4L6
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1
GSK Investigational Site
Vancouver, British Columbia, V7N 4M2
GSK Investigational Site
Winnipeg, Manitoba, R3E 3P4
GSK Investigational Site
Winnipeg, Manitoba, R3K 0Y8

Other trials in Canada

Puerto Rico2 sites

GSK Investigational Site
Rio Grande, Puerto Rico, 00745
GSK Investigational Site
San Juan, Puerto Rico, 00907

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-blind, Positive-Controlled, Multicenter Study Comparing the Efficacy of Carvedilol Phosphate Modified Release Formulation (COREG MR) and Metoprolol Succinate Extended Release (TOPROL-XL) on the Reduction of Microalbuminuria in Patients With Hypertension and Microalbuminuria

Conditions: Heart Failure, Congestive and Microalbuminuria
Being tested: metoprolol xl, carvedilol MR, lisinopril
Keywords: hypertension, urine albumin:creatinine ratio, microalbuminuria
Medical subject headings: Heart Failure, Hypertension

What participants receive

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

metoprolol xlDrug
carvedilol MRDrug
lisinoprilDrug
Also called carvedilol MR, metoprolol xl

What is being measured

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

Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy.
Measured: Baseline (Randomization Visit) and Month 6

Secondary outcomes (10)

Percentage of participants who achieved normoalbuminuria at 6 months of maintenance therapy.
Measured: Month 6
Percentage of participants who progressed to macroalbuminuria after 6 months of maintenance therapy.
Measured: Month 6
Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP)
Measured: Baseline (Randomization Visit) and Month 6
Change from Pre-screening visit to month 6 LOCF in urine ACR.
Measured: Pre-screening Visit and Month 6
Change from baseline to visit to month 6 LOCF in lipids including total cholesterol, low density lipid (LDL), high density lipid (HDL) and Triglycerides (TG)
Measured: Baseline (Randomization visit) and Month 6
Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment.
Measured: Baseline (Randomization Visit) and Month 6
Changes from baseline in heart rate at month 6 of treatment.
Measured: Baseline (Randomization visit) and Month 6
Percentage of participants who required add-on therapy to reach target blood pressure at any time during the study.
Measured: Up to 6 months
Number of participants with clinical chemistry parameters and hematology parameters of potential clinical concern at any time on-treatment.
Measured: Up to 6 months
Number of participants with vital signs of potential clinical concern at any time on-treatment.
Measured: Up to 6 months

Timeline

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

Jul 2005May 2006

First posted26 Jul 2005 (estimated)
Study startJul 2005
Primary completionMay 2006
Study completionMay 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Heart Failure, Congestive and MicroalbuminuriaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,220 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00123903
Sponsor's protocol ID: COR103560
Status last verified: Jan 2017
First submitted: 22 Jul 2005
Last updated: 18 Jan 2017
Results posted: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Positive-Controlled, Multicenter Study Comparing the Efficacy of Carvedilol Phosphate Modified Release Formulation (COREG MR) and Metoprolol Succinate Extended Release (TOPROL-XL) on the Reduction of Microalbuminuria in Patients With Hypertension and Microalbuminuria
ClinicalTrials.gov ID: NCT00123903
Acronym / sponsor ID: COR103560
Conditions: Heart Failure, Congestive and Microalbuminuria
Keywords: hypertension, urine albumin:creatinine ratio, microalbuminuria
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 1,220 participants
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: May 2006 (actual)
Study completion: May 2006 (actual)
First posted: 26 Jul 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Documented history of hypertension.
Must have been taking an ACE (angiotensin converting enzyme) inhibitor either alone or as part of an antihypertensive regimen for at least 8 weeks.
Persistent microalbuminuria.

Key exclusion criteria (2 listed)

History of heart attack, stroke, congestive heart failure, arrhythmia, type 1 or uncontrolled type 2 diabetes mellitus, liver or renal disease.
Has been taking any non-ocular beta-blockers for any indication within three months prior to Pre-screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
metoprolol xl	Drug	–
carvedilol MR	Drug	–
lisinoprilAlso: carvedilol MR, metoprolol xl	Drug	–

Primary outcome

Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy.
Time frame: Baseline (Randomization Visit) and Month 6

10 secondary outcomes

Percentage of participants who achieved normoalbuminuria at 6 months of maintenance therapy.
Time frame: Month 6
Percentage of participants who progressed to macroalbuminuria after 6 months of maintenance therapy.
Time frame: Month 6
Change from baseline to month 6 LOCF in High-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline (Randomization Visit) and Month 6
Change from Pre-screening visit to month 6 LOCF in urine ACR.
Time frame: Pre-screening Visit and Month 6
Change from baseline to visit to month 6 LOCF in lipids including total cholesterol, low density lipid (LDL), high density lipid (HDL) and Triglycerides (TG)
Time frame: Baseline (Randomization visit) and Month 6
Changes from baseline in blood pressure (systolic and diastolic) at month 6 of treatment.
Time frame: Baseline (Randomization Visit) and Month 6
Changes from baseline in heart rate at month 6 of treatment.
Time frame: Baseline (Randomization visit) and Month 6
Percentage of participants who required add-on therapy to reach target blood pressure at any time during the study.
Time frame: Up to 6 months
Number of participants with clinical chemistry parameters and hematology parameters of potential clinical concern at any time on-treatment.
Time frame: Up to 6 months
Number of participants with vital signs of potential clinical concern at any time on-treatment.
Time frame: Up to 6 months

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

94 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing metoprolol xl, carvedilol MR and lisinopril in people with Heart Failure, Congestive and Microalbuminuria, run by GlaxoSmithKline at 94 sites in 3 countries.

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 2 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: stopped early, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Canada, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early. Results are not available in the source record.

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?

Change from baseline in urine albumin: creatinine ratio (ACR) at six months of maintenance therapy. (time frame: Baseline (Randomization Visit) and Month 6). 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 NCT00123903.

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 18 Jan 2017.