MedDataX Logo

Trial Outcomes & Findings for Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease (NCT NCT00553969)

NCT ID: NCT00553969

Last Updated: 2018-04-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

101 participants

Primary outcome timeframe

Baseline and nine months

Results posted on

2018-04-24

Participant Flow

Participant milestones

Participant milestones
Measure
1 Coreg CR + Lisinopril
Coreg CR + lisinopril carvedilol 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
2 Coreg CR + Placebo
Coreg CR + placebo carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months
3 Lisinopril + Placebo
lisinopril + placebo lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months
4 Placebo + Placebo
Overall Study
STARTED
31
24
22
24
Overall Study
COMPLETED
23
24
21
23
Overall Study
NOT COMPLETED
8
0
1
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
1 Coreg CR + Lisinopril
n=23 Participants
Coreg CR + lisinopril carvedilol 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
2 Coreg CR + Placebo
n=24 Participants
Coreg CR + placebo carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months
3 Lisinopril + Placebo
n=21 Participants
lisinopril + placebo lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months
4 Placebo + Placebo
n=23 Participants
Total
n=91 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Age, Categorical
Between 18 and 65 years
23 Participants
n=5 Participants
24 Participants
n=7 Participants
21 Participants
n=5 Participants
23 Participants
n=4 Participants
91 Participants
n=21 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Age, Continuous
52 years
STANDARD_DEVIATION 13 • n=5 Participants
53 years
STANDARD_DEVIATION 10 • n=7 Participants
53 years
STANDARD_DEVIATION 10 • n=5 Participants
51 years
STANDARD_DEVIATION 13 • n=4 Participants
52.25 years
STANDARD_DEVIATION 11.5 • n=21 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
7 Participants
n=7 Participants
5 Participants
n=5 Participants
8 Participants
n=4 Participants
26 Participants
n=21 Participants
Sex: Female, Male
Male
17 Participants
n=5 Participants
17 Participants
n=7 Participants
16 Participants
n=5 Participants
15 Participants
n=4 Participants
65 Participants
n=21 Participants
Region of Enrollment
United States
23 participants
n=5 Participants
24 participants
n=7 Participants
21 participants
n=5 Participants
23 participants
n=4 Participants
91 participants
n=21 Participants

PRIMARY outcome

Timeframe: Baseline and nine months

Population: Calculation for change is the value at the later time point minus the value at the earlier time point.

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.

Outcome measures

Outcome measures
Measure
1 Coreg CR + Lisinopril
n=23 Participants
Coreg CR + lisinopril carvedilol 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
2 Coreg CR + Placebo
n=24 Participants
Coreg CR + placebo carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months
3 Lisinopril + Placebo
n=21 Participants
lisinopril + placebo lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months
4 Placebo + Placebo
n=23 Participants
Change in Disease Score (DS) Among the Treatment Groups
-2.48 Overall Rasmussen Disease Score Change
Standard Deviation 1.9
-2.29 Overall Rasmussen Disease Score Change
Standard Deviation 2.3
-2.38 Overall Rasmussen Disease Score Change
Standard Deviation 2.6
-0.96 Overall Rasmussen Disease Score Change
Standard Deviation 1.5

Adverse Events

1 Coreg CR + Lisinopril

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

2 Coreg CR + Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

3 Lisinopril + Placebo

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

4 Placebo + Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
1 Coreg CR + Lisinopril
n=31 participants at risk
Coreg CR + lisinopril carvedilol 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
2 Coreg CR + Placebo
n=24 participants at risk
Coreg CR + placebo carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months
3 Lisinopril + Placebo
n=22 participants at risk
lisinopril + placebo lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months
4 Placebo + Placebo
n=24 participants at risk
Vascular disorders
stroke
0.00%
0/31
0.00%
0/24
4.5%
1/22
0.00%
0/24

Other adverse events

Adverse event data not reported

Additional Information

Jay N. Cohn, M.D.

University of Minnesota Medical School

Phone: 612.625.5646

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place