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See the termination reason in detailed description.
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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CADUET (AMLODIPINE 5 mg/ATORVASTATIN 10 mg or 20 mg) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic and Diastolic Blood Pressure | No efficacy results were available from this terminated study. | Baseline, 24 weeks |
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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:
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Patients will be treated in this study according to prevailing local clinical practice following the locally approved product labeled recommendations
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Systolic and Diastolic Blood Pressure | No efficacy results were available from this terminated study. | Posted | Baseline, 24 weeks |
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|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High Density Lipoprotein decreased | Investigations | MedDRA v11.1 | Systematic Assessment |
The objectives for this terminated study could not be assessed due to limited data available. (Efficacy parameters were to include BP, heart rate, lipid profile, urine albumin.)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C487936 | amlodipine, atorvastatin drug combination |
| D017311 | Amlodipine |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 0 |
| 112 |
| 1 |
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.
| D011758 |
| Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |