Hypertension and Cardiovascular Risk Factors
Conditions
Keywords
Efficacy,safety & tolerability of Caduet In Patients With Cardiovascular Risk Factors
Brief summary
To assess the effect of single pill therapy on the management of hypertension and other cardiovascular risk factors (e.g., dyslipidemia) in Indian patients in whom the treating doctor has already considered that the administration of the amlodipine/atorvastatin single pill to be appropriate
Detailed description
Patients who have been prescribed single pill Caduet are eligible to participate in this study. The treating physician will obtain written informed consent from each subject or the subject's legally acceptable representative before any study-specific activity is performed. The study terminated on May 5, 2008. The decision to terminate was due to inability to achieve study timelines and undue delay in obtaining IEC/IRB permission at some sites. No safety or efficacy issues caused the decision to terminate.
Interventions
DRUGCADUET (AMLODIPINE 5 mg/ATORVASTATIN 10 mg or 20 mg)
Patients who have been treated with Caduet 5/10 or 5/20 mg single pill treatment, based on their clinical conditions and latest locally approved packet insert recommendations will be eligible to be enrolled to this study
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who have been prescribed single pill Caduet are eligible to participate in this study. Patients will be treated in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
Exclusion criteria
* Known hypersensitivity to dihydropyridines, amlodipine, atorvastatin, or any component of this medication, * Active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal, * Or who are pregnant, breast-feeding, or of childbearing potential who are not using adequate contraceptive measures. Amlodipine/atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards to the fetus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic and Diastolic Blood Pressure | Baseline, 24 weeks | No efficacy results were available from this terminated study. |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 112 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discontinued when study terminated | 73 |
| Overall Study | Lost to Follow-up | 39 |
Baseline characteristics
| Characteristic | Caduet |
|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 9.6 |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / — |
| serious Total, serious adverse events | 0 / 112 |
Outcome results
Primary
Change in Systolic and Diastolic Blood Pressure
No efficacy results were available from this terminated study.
Time frame: Baseline, 24 weeks