CompletedNCT00553969DETECTUpdated Apr 24, 2018Results posted

Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease

A Phase 1/2 interventional study of carvedilol phosphate and lisinopril in Pre-hypertension, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-04-24.

Sponsored by University of Minnesota · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 101
Allocation: Randomized
Ages: 19 Years and older
Sex: All

Study summary

This study will examine the individual and combined effects of Coreg CR and lisinopril, on cardiovascular health as measured by Rasmussen Disease Score (RDS) in a blinded, placebo controlled comparison over a 9-month study period. Patients to be randomized will have pre-hypertensive blood pressures that do not require anti-hypertensive therapy and at least one additional cardiovascular risk factor.

Read the detailed description

This study will compare the effect of Coreg CR and lisinopril, separately and together, on Rasmussen Disease Score in a controlled study with an inactive substance (placebo).
Study patients will have pre-hypertensive (slightly elevated) blood pressures not requiring therapy.
Lisinopril is an angiotensin converting enzyme (ACE) inhibitor. Angiotensin is a chemical that is made by the body continuously. Angiotensin narrows blood vessels and thereby maintains (elevates) blood pressure. When the enzyme is blocked by lisinopril, angiotensin cannot be converted into its active form. As a result, blood pressure is lowered. Lisinopril is a drug that has been approved for use by the U.S. Food and Drug Administration (FDA) and health authorities for the treatment of high blood pressure and heart failure.
Coreg CR is a once-a-day heart medication that is part of a class of drugs known as beta-blockers. Beta-blockers prevent beta-adrenergic substances such as adrenaline from activating parts of the nervous system, including the heart. Beta-blockers therefore relieve stress on the heart by slowing heart beat, decreasing the force of heart muscle contractions, and reducing blood pressure. Coreg has also been approved by the FDA for the treatment of hypertension and various other cardiovascular conditions.
It is possible that the beta blocker could increase the benefits of the ACE inhibitor by inhibiting renin production, which is an important step in angiotensin production. These two drugs may act together to provide even more protection to blood vessels and the heart.

Conditions studied

Pre-hypertension

Browse trials for

Prehypertension 145

Keywords

cardiovascular disease prevention

In context

Prehypertension

145 studies on the registry are indexed under Prehypertension; 21 are open to participants now.

This study's enrollment of 101 is above the median of 62 across 127 interventional studies indexed under Prehypertension.

Browse Prehypertension studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Males and females > 18 years old with pre-hypertensive or borderline blood pressures (systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg) deemed not to need antihypertensive therapy. Subjects must also have one additional risk factor for cardiovascular disease, including:
LDL > 130 and \< 160 mg/dL
HDL \< 40 mg/dL
Fasting blood sugar >100 and \< 126 mg/dL
Body mass index ≥ 30
Smoker
Family history of premature heart disease or hypertension

Exclusion criteria

Exclusion Criteria:

Patients with a history of cardiac, cerebral or other vascular events within the previous 6 months will be excluded. Other exclusions include background therapy with a beta blocker or ACE inhibitor therapy, known or suspected intolerance to beta blockers or ACE inhibitors, angiotensin receptor blocker therapy, or diabetes. Pregnant or lactating women, and women of child-bearing age who are not using an acceptable form of contraception are also excluded from this study.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 101 participants (actual)

Study arms

Experimental
1
Coreg CR + lisinopril
Drug: carvedilol phosphate and lisinopril
Experimental
2
Coreg CR + placebo
Drug: carvedilol phosphate
Experimental
3
lisinopril + placebo
Drug: lisinopril
Placebo comparator
4
placebo + placebo
Drug: placebo and placebo

Interventions

Drugcarvedilol phosphate
Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months
Also known as: Coreg CR
Druglisinopril
tablets, 10mg once daily for 1 month, 20mg once daily for 8 months
Drugcarvedilol phosphate and lisinopril
carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months
Also known as: Coreg CR (carvedilol phosphate)
Drugplacebo and placebo
capsule once daily for 9 months; dosage unknown

What researchers measure

Primary outcomes

Change in Disease Score (DS) Among the Treatment Groups
Rasmussen Disease Score (RDS) Change From Baseline to 9 Months A score of six or higher on these tests means the patient likely has plaque build-up in the arteries, or atherosclerosis, while a score of three to five suggests that such a problem may be developing. A score of two or less signals a patient is fine but should return in the future for another test. The method detects disease at the earliest moment, before the traditionally used calcium score would show any signs of trouble.
Time frame: Baseline and nine months

Results

Posted Dec 17, 2014

Participant flow

Participant flow — Overall Study
Milestone	1 Coreg CR + Lisinopril	2 Coreg CR + Placebo	3 Lisinopril + Placebo	4 Placebo + Placebo
Started	31	24	22	24
Completed	23	24	21	23
Not completed	8	0	1	1

Outcome measures

PrimaryChange in Disease Score (DS) Among the Treatment Groups

Rasmussen Disease Score (RDS) Change From Baseline to 9 Months A score of six or higher on these tests means the patient likely has plaque build-up in the arteries, or atherosclerosis, while a score of three to five suggests that such a problem may be developing. A score of two or less signals a patient is fine but should return in the future for another test. The method detects disease at the earliest moment, before the traditionally used calcium score would show any signs of trouble.

Time frame:: Baseline and nine months
Reported as:: Mean · Overall Rasmussen Disease Score Change

Change in Disease Score (DS) Among the Treatment Groups
Overall Rasmussen Disease Score Change	1 Coreg CR + Lisinopril	2 Coreg CR + Placebo	3 Lisinopril + Placebo	4 Placebo + Placebo
Change in Disease Score (DS) Among the Treatment Groups	-2.48 ± 1.9	-2.29 ± 2.3	-2.38 ± 2.6	-0.96 ± 1.5

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
1 Coreg CR + Lisinopril	—	0/31 (0%)	0/31 (0%)
2 Coreg CR + Placebo	—	0/24 (0%)	0/24 (0%)
3 Lisinopril + Placebo	—	1/22 (4.5%)	0/22 (0%)
4 Placebo + Placebo	—	0/24 (0%)	0/24 (0%)

Most frequent serious events

Most frequent serious events
Event	1 Coreg CR + Lisinopril	2 Coreg CR + Placebo	3 Lisinopril + Placebo	4 Placebo + Placebo
strokeVascular disorders	0/31	0/24	1/22	0/24

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	1 Coreg CR + Lisinopril	2 Coreg CR + Placebo	3 Lisinopril + Placebo	4 Placebo + Placebo	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	23	24	21	23	91
>=65 years	0	0	0	0	0

Age, Continuous
Age, Continuous(years)	1 Coreg CR + Lisinopril	2 Coreg CR + Placebo	3 Lisinopril + Placebo	4 Placebo + Placebo	Total
Mean	52 ± 13	53 ± 10	53 ± 10	51 ± 13	52.25 ± 11.5

Sex: Female, Male
Sex: Female, Male(Participants)	1 Coreg CR + Lisinopril	2 Coreg CR + Placebo	3 Lisinopril + Placebo	4 Placebo + Placebo	Total
Female	6	7	5	8	26
Male	17	17	16	15	65

Region of Enrollment
Region of Enrollment(participants)	1 Coreg CR + Lisinopril	2 Coreg CR + Placebo	3 Lisinopril + Placebo	4 Placebo + Placebo	Total
United States	23	24	21	23	91

Study locations

1 site

University of Minnesota, Variety Club Research Center 102
Minneapolis, Minnesota 55455, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00553969
Lead sponsor: University of Minnesota
Collaborators: GlaxoSmithKline
Responsible party: Sponsor
First posted: Nov 6, 2007
Start date: Nov 2007
Primary completion: Sep 2010
Completion: Dec 2010
Results posted: Dec 17, 2014
Last update: Apr 24, 2018

Study contacts

Jay N Cohn, MD

principal investigator · Professor, University of Minnesota, Cardiology Division

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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