CUSP: Caduet in an Untreated Subject Population

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00332761
• Collaborator: (none)
• Enrollment: 220
• Locations: 34
• Duration (Months): 15
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Dyslipidemia	Drug: Caduet	Phase 4

Study Design

• Study Type: Interventional
• 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: Jun 1, 2006
• Actual Study Completion Date: Sep 1, 2007

Outcome Measures

Primary Outcome Measures

1. The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4. []

Secondary Outcome Measures

1. The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 8. []

2. Change from Baseline to Week 4 in SBP, DBP, and Framingham 10-year CHD risk score. []

3. Percent change from Baseline to Week 4 in LDL-C, HDL, TC, and TG. []

4. The percentage of study subjects achieving each of the following goals at Week 4: SBP, DBP, and LDL-C. []

5. Change from Baseline to Week 8 in SBP, DBP, and Framingham 10-year CHD risk score. []

6. Percent change from Baseline to Week 8 in LDL-C, HDL, TC, and TG. []

7. The percentage of study subjects achieving each of SBP, DBP, and LDL-C goals at Week 8. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Jonesboro	Arkansas	United States	72401
2	Pfizer Investigational Site	Little Rock	Arkansas	United States	72204
3	Pfizer Investigational Site	Garden Grove	California	United States	92843
4	Pfizer Investigational Site	Long Beach	California	United States	90806
5	Pfizer Investigational Site	Tustin	California	United States	92780
6	Pfizer Investigational Site	Aventura	Florida	United States	33180
7	Pfizer Investigational Site	Fort Lauderdale	Florida	United States	33308
8	Pfizer Investigational Site	Miami	Florida	United States	33137
9	Pfizer Investigational Site	Pembroke Pines	Florida	United States	33027
10	Pfizer Investigational Site	Atlanta	Georgia	United States	30309
11	Pfizer Investigational Site	Decatur	Georgia	United States	30033
12	Pfizer Investigational Site	Bossier City	Louisiana	United States	71111
13	Pfizer Investigational Site	Fair Haven	Michigan	United States	48023
14	Pfizer Investigational Site	Livonia	Michigan	United States	48152
15	Pfizer Investigational Site	Jackson	Mississippi	United States	39201
16	Pfizer Investigational Site	Jackson	Mississippi	United States	39202
17	Pfizer Investigational Site	Excelsior Springs	Missouri	United States	64024
18	Pfizer Investigational Site	Berlin	New Jersey	United States	08009
19	Pfizer Investigational Site	Elizabeth	New Jersey	United States	07202
20	Pfizer Investigational Site	Princeton	New Jersey	United States	08540
21	Pfizer Investigational Site	South Bound Brook	New Jersey	United States	08880
22	Pfizer Investigational Site	Binghamton	New York	United States	13901
23	Pfizer Investigational Site	Monroe	North Carolina	United States	28112
24	Pfizer Investigational Site	Winston-Salem	North Carolina	United States	27103
25	Pfizer Investigational Site	Cincinnati	Ohio	United States	45236
26	Pfizer Investigational Site	Dayton	Ohio	United States	45406-5144
27	Pfizer Investigational Site	Eugene	Oregon	United States	97404
28	Pfizer Investigational Site	Bensalem	Pennsylvania	United States	19020
29	Pfizer Investigational Site	Kingsport	Tennessee	United States	37660
30	Pfizer Investigational Site	Beaumont	Texas	United States	77702
31	Pfizer Investigational Site	Colleyville	Texas	United States	76034
32	Pfizer Investigational Site	Houston	Texas	United States	77030
33	Pfizer Investigational Site	Temple	Texas	United States	76502
34	Pfizer Investigational Site	Norfolk	Virginia	United States	23510

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00332761
• Other Study ID Numbers: A3841046
• First Posted: Jun 2, 2006
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Additional relevant MeSH terms: Dyslipidemias; Amlodipine, atorvastatin drug combination

Study Results

No Results Posted as of Jan 27, 2021