Trial Outcomes & Findings for Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors (NCT NCT00579254)
NCT ID: NCT00579254
Last Updated: 2021-01-28
Results Overview
No efficacy results were available from this terminated study.
Recruitment status
TERMINATED
Target enrollment
112 participants
Primary outcome timeframe
Baseline, 24 weeks
Results posted on
2021-01-28
Participant Flow
This was a phase 4, observational, open-label study conducted in patients who were prescribed singlepill Caduet by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.
Participant milestones
| Measure |
Caduet
Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
|
|---|---|
|
Overall Study
STARTED
|
112
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
112
|
Reasons for withdrawal
| Measure |
Caduet
Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
39
|
|
Overall Study
Discontinued when study terminated
|
73
|
Baseline Characteristics
Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors
Baseline characteristics by cohort
| Measure |
Caduet
n=112 Participants
Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
|
|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksNo efficacy results were available from this terminated study.
Outcome measures
Outcome data not reported
Adverse Events
Caduet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Caduet
n=112 participants at risk
Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
|
|---|---|
|
Investigations
High Density Lipoprotein decreased
|
0.89%
1/112
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER