HypertensionPhase 4CUSPNCT00332761
Caduet in an Untreated Subject Population
A Phase 4 study testing Caduet in people with Hypertension and Dyslipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 34 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- Caduet
- How many people
- 220 participants
- Where
- 34 sitesUnited States
- Study dates
- Jun 2006to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Aventura, Florida, 33180
Pfizer Investigational Site
Beaumont, Texas, 77702
Pfizer Investigational Site
Bensalem, Pennsylvania, 19020
Pfizer Investigational Site
Berlin, New Jersey, 08009
Pfizer Investigational Site
Binghamton, New York, 13901
Pfizer Investigational Site
Bossier City, Louisiana, 71111
Pfizer Investigational Site
Cincinnati, Ohio, 45236
Pfizer Investigational Site
Colleyville, Texas, 76034
Pfizer Investigational Site
Dayton, Ohio, 45406-5144
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Elizabeth, New Jersey, 07202
Pfizer Investigational Site
Eugene, Oregon, 97404
Pfizer Investigational Site
Excelsior Springs, Missouri, 64024
Pfizer Investigational Site
Fair Haven, Michigan, 48023
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308
Pfizer Investigational Site
Garden Grove, California, 92843
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Jackson, Mississippi, 39201
Pfizer Investigational Site
Jackson, Mississippi, 39202
Pfizer Investigational Site
Jonesboro, Arkansas, 72401
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Little Rock, Arkansas, 72204
Pfizer Investigational Site
Livonia, Michigan, 48152
Pfizer Investigational Site
Long Beach, California, 90806
Pfizer Investigational Site
Miami, Florida, 33137
Pfizer Investigational Site
Monroe, North Carolina, 28112
Pfizer Investigational Site
Norfolk, Virginia, 23510
Pfizer Investigational Site
Pembroke Pines, Florida, 33027
Pfizer Investigational Site
Princeton, New Jersey, 08540
Pfizer Investigational Site
South Bound Brook, New Jersey, 08880
Pfizer Investigational Site
Temple, Texas, 76502
Pfizer Investigational Site
Tustin, California, 92780
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
About this study
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)
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.
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- Caduet
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaduetDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.
Secondary outcomes (7)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startJun 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332761
- Sponsor's protocol ID
- A3841046
- Acronym
- CUSP
- Status last verified
- Jan 2021
- First submitted
- 1 Jun 2006
- Last updated
- 27 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00332761
- Acronym / sponsor ID
- CUSP / A3841046
- Conditions
- Hypertension, Dyslipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 2 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caduet | Drug | – |
Primary outcome
The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.
7 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caduet in people with Hypertension and Dyslipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.