Caduet in an Untreated Subject Population (CUSP)
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ClinicalTrials.gov Identifier: NCT00332761 |
Recruitment Status
:
Completed
First Posted
: June 2, 2006
Last Update Posted
: August 20, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension Dyslipidemia | Drug: Caduet | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 220 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | An 8-Week Randomized, Double-Blind, Placebo-Controlled Trial Examining The Efficacy And Safety Of Caduet® In Simultaneously Achieving Blood Pressure And Lipid Goals In An Untreated Hypertensive And Dyslipidemic Subject Population. (CUSP - Caduet in Untreated Subject Population) |
Study Start Date : | June 2006 |
Actual Study Completion Date : | September 2007 |

- The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.
- The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 8.
- Change from Baseline to Week 4 in SBP, DBP, and Framingham 10-year CHD risk score.
- Percent change from Baseline to Week 4 in LDL-C, HDL, TC, and TG.
- The percentage of study subjects achieving each of the following goals at Week 4: SBP, DBP, and LDL-C.
- Change from Baseline to Week 8 in SBP, DBP, and Framingham 10-year CHD risk score.
- Percent change from Baseline to Week 8 in LDL-C, HDL, TC, and TG.
- The percentage of study subjects achieving each of SBP, DBP, and LDL-C goals at Week 8.

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects who were recently diagnosed with both hypertension and dyslipidemia and who are not yet taking any medications for these conditions OR subjects with both hypertension and dyslipidemia who were previously treated with antihypertensive and/or lipid lowering medications but discontinued these medications for at least 3 months prior to the Screening visit.
- SBP 140-169 mmHg and/or DBP 90-105 mmHg, LDL-C 110-160 mg/dL
Exclusion Criteria:
- Subjects with a history of MI, angina, coronary artery bypass or intra-coronary interventions, stroke, TIA, CHF or cardiomyopathy requiring treatment.
- Subjects with a known history of Type I or Type 2 Diabetes Mellitus or a fasting blood glucose > 126 mg/dL at the Screening visit.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332761

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00332761 History of Changes |
Other Study ID Numbers: |
A3841046 |
First Posted: | June 2, 2006 Key Record Dates |
Last Update Posted: | August 20, 2008 |
Last Verified: | August 2008 |
Additional relevant MeSH terms:
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Amlodipine, atorvastatin drug combination Anticholesteremic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |