Phase 4
N=1,461
Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors
Hypertension · Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00407537 ↗Enrolled (actual)
1,461
Serious AEs
5.0%
Results posted
Nov 2011
Primary outcome: Primary: Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 — 12.5; 16.3 percent risk — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Amlodipine besylate/atorvastatin calcium single pill combination (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 |
12.5; 16.3 | <0.001 sig |
| SECONDARY Framingham 10-year Risk of Total CHD at Month 4 |
12.5; 16.3 | <0.001 sig |
| SECONDARY European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12 |
3.0; 3.7 | <0.001 sig |
| SECONDARY European SCORE 10-year Risk of Fatal CVD at Month 4 |
3.1; 3.7 | <0.001 sig |
| SECONDARY Framingham 10-year Risk of Stroke at Month 12 |
3.7; 4.9 | <0.001 sig |
| SECONDARY Framingham 10-year Risk of Stroke at Month 4 |
3.7; 4.9 | <0.001 sig |
| SECONDARY Change From Baseline in Framingham 10-year Risk of Developing Total CHD |
-7.2705; -2.5155; -7.2374; -2.5167 | — |
| SECONDARY Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD |
-1.8438; -0.9678; -1.9693; -0.9963 | — |
| SECONDARY Mean Systolic and Diastolic Blood Pressure at Month 4 |
133.5; 134.5; 80.7; 81.1 | — |
| SECONDARY Mean Systolic and Diastolic Blood Pressure at Month 12 |
130.6; 134.3; 79.2; 81.1 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) at Month 4 |
-15.3088; -12.1619 | <0.007 sig |
| SECONDARY Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4 |
-8.3024; -6.6908 | <0.011 sig |
| SECONDARY Change From Baseline in SBP at Month 12 |
-18.2409; -12.4903 | <0.001 sig |
| SECONDARY Change From Baseline in DBP at Month 12 |
-10.0128; -6.8429 | <0.001 sig |
| SECONDARY Mean Lipid Parameters at Month 4 |
156.0; 195.2; 80.9; 116.4; 47.6; 46.8 | <0.001 sig |
| SECONDARY Mean Lipid Parameters at Month 12 |
163.3; 196.6; 87.1; 117.3; 47.3; 47.1 | <0.001 sig |
| SECONDARY Change From Baseline in Lipid Parameters at Month 4 |
-42.7542; -3.8144; -38.2765; -2.9628; -0.2060; -1.1978 | <0.001 sig |
| SECONDARY Change From Baseline in Lipid Parameters at Month 12 |
-37.1024; -4.0368; -33.2420; -3.4168; -0.4339; -1.0105 | <0.001 sig |
| SECONDARY Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months |
65.2; 62.6; 76.1; 60.6; 48.6; 46.0 | — |
| SECONDARY Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months |
77.3; 28.2; 71.9; 28.8; 52.4; 13.3 | — |
| SECONDARY Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months |
648; 642; 647; 637; 45; 202 | — |
| SECONDARY Number of Participants With Increase of Treatment Dosages After 4 Months. |
30; 90; 30; 88; 0; 2 | — |
Summary
To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.
Eligibility Criteria
Inclusion Criteria
- Hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women)
Exclusion Criteria
- Subjects currently receiving a statin or stopped statin within 6 months prior to enrollment.
- Subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.
Data sourced from ClinicalTrials.gov (NCT00407537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.