Trial · NCT00407537
Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors
NCT00407537, Phase 4, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-11-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors. Trials, record NCT00407537. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00407537
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors
- NCT number
- NCT00407537
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,531 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Hypertension, Hypercholesterolemia
- Interventions
- Amlodipine besylate/atorvastatin calcium single pill combination
- First posted
- 2006-12-05
- Last updated
- 2021-01-28
- Results first posted
- 2011-11-11
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 | Baseline, Month 12 | Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12). |
| Secondary | Framingham 10-year Risk of Total CHD at Month 4 | Baseline, Month 4 | Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated after 4 months of treatment (Month 4). |
| Secondary | European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12 | Baseline, Month 12 | European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12). |
| Secondary | European SCORE 10-year Risk of Fatal CVD at Month 4 | Baseline, Month 4 | European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 4 months of study treatment (Month 4). |
| Secondary | Framingham 10-year Risk of Stroke at Month 12 | Baseline, Month 12 | Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific "calibration factor" for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12). |
| Secondary | Framingham 10-year Risk of Stroke at Month 4 | Baseline, Month 4 | Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific "calibration factor" for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12). |
| Secondary | Change From Baseline in Framingham 10-year Risk of Developing Total CHD | Baseline, Month 4, Month 12 | Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. Change from baseline calculated as mean at observation minus mean at Baseline. |
| Secondary | Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD | Baseline, Month 4, Month 12 | European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline. |
| Secondary | Mean Systolic and Diastolic Blood Pressure at Month 4 | Month 4 | |
| Secondary | Mean Systolic and Diastolic Blood Pressure at Month 12 | Month 12 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 | Baseline, Month 12 | Full Analysis Set (FAS) included all subjects, in either treatment group, who had blood pressure and lipid data from at least 1 follow-up visit. Number of participants analyzed refers to number of participants contributing to data. | percent risk | MEAN |
| SECONDARY | Framingham 10-year Risk of Total CHD at Month 4 | Baseline, Month 4 | FAS. Number of participants analyzed refers to number of participants contributing to data. | percent risk | MEAN |
| SECONDARY | European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12 | Baseline, Month 12 | FAS. Number of participants analyzed refers to number of participants contributing to data. | percent risk | MEAN |
| SECONDARY | European SCORE 10-year Risk of Fatal CVD at Month 4 | Baseline, Month 4 | FAS. Number of participants analyzed refers to number of participants contributing to data. | percent risk | MEAN |
| SECONDARY | Framingham 10-year Risk of Stroke at Month 12 | Baseline, Month 12 | FAS. Number of participants analyzed refers to number of participants contributing to data. | percent risk | MEAN |
| SECONDARY | Framingham 10-year Risk of Stroke at Month 4 | Baseline, Month 4 | FAS. Number of participants analyzed refers to number of participants contributing to data. | percent risk | MEAN |
| SECONDARY | Change From Baseline in Framingham 10-year Risk of Developing Total CHD | Baseline, Month 4, Month 12 | FAS. Number of participants analyzed refers to number of participants contributing to data. | percent risk | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD | Baseline, Month 4, Month 12 | FAS. Number of participants analyzed refers to number of participants contributing to data. | percent risk | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Systolic and Diastolic Blood Pressure at Month 4 | Month 4 | FAS. Number of participants analyzed refers to number of participants contributing data. | mmHg | MEAN |
| SECONDARY | Mean Systolic and Diastolic Blood Pressure at Month 12 | Month 12 | FAS. Number of participants analyzed refers to number of participants contributing to data. | mmHg | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 | Caduet | 12.5 | Standard Deviation 8.26 | percent risk | |
| Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 | Usual Care | 16.3 | Standard Deviation 10.51 | percent risk | |
| Framingham 10-year Risk of Total CHD at Month 4 | Caduet | 12.5 | Standard Deviation 7.96 | percent risk | |
| Framingham 10-year Risk of Total CHD at Month 4 | Usual Care | 16.3 | Standard Deviation 10.80 | percent risk | |
| European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12 | Caduet | 3.0 | Standard Deviation 2.89 | percent risk | |
| European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12 | Usual Care | 3.7 | Standard Deviation 3.69 | percent risk | |
| European SCORE 10-year Risk of Fatal CVD at Month 4 | Caduet | 3.1 | Standard Deviation 3.13 | percent risk | |
| European SCORE 10-year Risk of Fatal CVD at Month 4 | Usual Care | 3.7 | Standard Deviation 3.69 | percent risk | |
| Framingham 10-year Risk of Stroke at Month 12 | Caduet | 3.7 | Standard Deviation 2.25 | percent risk | |
| Framingham 10-year Risk of Stroke at Month 12 | Usual Care | 4.9 | Standard Deviation 2.87 | percent risk |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Caduet | 779 | |
| Overall Study | STARTED | Usual Care | 682 | |
| Overall Study | Eligible for Efficacy Analysis | Caduet | 760 | |
| Overall Study | Eligible for Efficacy Analysis | Usual Care | 657 | |
| Overall Study | COMPLETED | Caduet | 686 | |
| Overall Study | COMPLETED | Usual Care | 638 | |
| Overall Study | NOT COMPLETED | Caduet | 93 | |
| Overall Study | NOT COMPLETED | Usual Care | 44 |
Source ClinicalTrials.gov
Adverse events886
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Caduet | 1 | 779 | |
| other | Anaemia | Blood and lymphatic system disorders | Usual Care | 1 | 682 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Caduet | 0 | 779 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Usual Care | 1 | 682 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Caduet | 1 | 779 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Usual Care | 0 | 682 | |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Caduet | 1 | 779 | |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Usual Care | 0 | 682 | |
| other | Angina pectoris | Cardiac disorders | Caduet | 2 | 779 | |
| other | Angina pectoris | Cardiac disorders | Usual Care | 0 | 682 |
1 to 10 of 886Source ClinicalTrials.gov
See all 886 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Caduet | ||
| Total, all-cause mortality | Usual Care | ||
| Total, other adverse events | Caduet | 356 | 779 |
| Total, other adverse events | Usual Care | 289 | 682 |
| Total, serious adverse events | Caduet | 51 | 779 |
| Total, serious adverse events | Usual Care | 22 | 682 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Caduet vs Usual Care: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00407537
GET https://conductscience.org/api/trials/v1/NCT00407537/registered?page=2