Caduet in an Untreated Subject Population (CUSP)

• ClinicalTrials.gov Identifier: NCT00332761
• Recruitment Status: Completed
• First Posted: June 2, 2006
• Last Update Posted: January 27, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: June 1, 2006
• First Posted Date: June 2, 2006
• Last Update Posted Date: January 27, 2021
• Study Start Date: June 2006
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: June 1, 2006): The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 1, 2006)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Caduet in an Untreated Subject Population
• 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)
• Brief Summary: The purpose of this study is to determine if Caduet will lower blood pressure to <140/90 mmHg and lower LDL Cholesterol to <100 mg/dL in subjects with hypertension and dyslipidemia who are not currently being treated for these medical conditions.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment

Condition

• Hypertension
• Dyslipidemia

• Intervention: Drug: Caduet
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 1, 2006): 220
• Original Enrollment: Same as current
• Actual Study Completion Date: September 2007
• Primary Completion Date: Not Provided

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00332761
• Other Study ID Numbers: A3841046
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: January 2021