HypertensionPhase 4CAPABLENCT00150384
Clinical Utility of Caduet in Achieving Blood Pressure and Lipid Endpoints in a Specific Patient Population
A Phase 4 study testing Amlodipine/Atorvastatin in people with Hypertension and Dyslipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 106 sites in United States.
Trial summary
The purpose is to demonstrate the utility of Caduet (amlodipine/atorvastatin) in the African American population Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- Amlodipine/Atorvastatin
- How many people
- 500 participants
- Where
- 106 sitesUnited States
- Study dates
- Jul 2004to Aug 2005
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American men and women with concurrent hypertension and dyslipidemia that is either treated or untreated
- Subjects must satisfy the blood pressure and LDL-C inclusion criteria for their respective Cardiovascular Risk group determined at screening
Who cannot join
- Subjects currently being treated with concomitant amlodipine and atorvastatin therapy, including Caduet
- Subjects with blood pressure at goal
Trial locations and contacts
106 sites in 1 country.
106 sites in 1 country
United States106 sites
Pfizer Investigational Site
Athens, Georgia, 30606
Pfizer Investigational Site
Atlanta, Georgia, 30303
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Atlanta, Georgia, 30310
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Augusta, Georgia, 30904
Pfizer Investigational Site
Aventura, Florida, 33180
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Baltimore, Maryland, 21215
Pfizer Investigational Site
Bamberg, South Carolina, 29003
Pfizer Investigational Site
Bartlett, Tennessee, 38134
Pfizer Investigational Site
Beaumont, Texas, 77702
Pfizer Investigational Site
Bensalem, Pennsylvania, 19020
Pfizer Investigational Site
Birmingham, Alabama, 35209
Pfizer Investigational Site
Birmingham, Alabama, 35211
Pfizer Investigational Site
Bossier City, Louisiana, 71111
Pfizer Investigational Site
Bridgeport, Connecticut, 6610
Pfizer Investigational Site
Brockton, Massachusetts, 02301
Pfizer Investigational Site
Brooklyn, New York, 11203
Pfizer Investigational Site
Brooklyn, New York
Pfizer Investigational Site
Buffalo, New York, 14215
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Charlotte, North Carolina, 28209
Pfizer Investigational Site
Cherry Hill, New Jersey, 08034
Pfizer Investigational Site
Chicago, Illinois, 60616
Pfizer Investigational Site
Chicago, Illinois, 60637-1470
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cincinnati, Ohio, 45229
Pfizer Investigational Site
Cincinnati, Ohio, 45236
Pfizer Investigational Site
Cincinnati, Ohio, 45246
Pfizer Investigational Site
Clinton, South Carolina, 29325
Pfizer Investigational Site
Columbia, Maryland, 21045
Pfizer Investigational Site
Columbus, Georgia, 31901
Pfizer Investigational Site
Columbus, Georgia, 31904
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
Dallas, Texas, 75254
Pfizer Investigational Site
Dayton, Ohio, 45402
Pfizer Investigational Site
Dayton, Ohio, 45406
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Detroit, Michigan, 48235
Pfizer Investigational Site
East Orange, New Jersey, 07018
Pfizer Investigational Site
Elizabeth, New Jersey, 07202
Pfizer Investigational Site
Emporia, Virginia, 23847
Pfizer Investigational Site
Gainesville, Florida, 32601
Pfizer Investigational Site
Greenville, North Carolina, 27834
Pfizer Investigational Site
Hammonton, New Jersey, 08037
Pfizer Investigational Site
Houston, Texas, 77024
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Houston, Texas, 77054
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Jackson, Mississippi, 39202
Pfizer Investigational Site
Jackson, Mississippi, 39216
Pfizer Investigational Site
Jackson, Tennessee, 38305
Pfizer Investigational Site
Jacksonville, Florida, 32204
Pfizer Investigational Site
Kansas City, Missouri, 64112
Pfizer Investigational Site
Kansas City, Missouri, 64131
Pfizer Investigational Site
Lansing, Michigan, 48917
Pfizer Investigational Site
Lincolnton, Georgia, 30817
Pfizer Investigational Site
Little Rock, Arkansas, 72204
Pfizer Investigational Site
Livonia, Michigan, 48152
Pfizer Investigational Site
Los Angeles, California, 90024
Pfizer Investigational Site
Maumee, Ohio, 43537
Pfizer Investigational Site
Maywood, Illinois, 60153
Pfizer Investigational Site
Merrillville, Indiana, 46410
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
Mineola, New York, 11501
Pfizer Investigational Site
Monroe, North Carolina, 28112
Pfizer Investigational Site
Monroe, North Carolina
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
New Orleans, Louisiana, 70117-4817
Pfizer Investigational Site
New Orleans, Louisiana, 70125
Pfizer Investigational Site
Norfolk, Virginia, 23502
Pfizer Investigational Site
Norfolk, Virginia, 23510
Pfizer Investigational Site
Oakland, California, 94609-3425
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Pensacola, Florida, 32503
Pfizer Investigational Site
Perrysburg, Ohio, 43551
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19141
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19146
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19148
Pfizer Investigational Site
Pico Rivera, California, 90660
Pfizer Investigational Site
Randallstown, Maryland, 21133
Pfizer Investigational Site
Richmond, Virginia, 23249
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Rockville, Maryland, 20850
Pfizer Investigational Site
Savannah, Georgia, 31406
Pfizer Investigational Site
Shreveport, Louisiana, 71101
Pfizer Investigational Site
Shreveport, Louisiana, 71130
Pfizer Investigational Site
Simpsonville, South Carolina, 29681
Pfizer Investigational Site
South Bound Brook, New Jersey, 08880
Pfizer Investigational Site
St Louis, Missouri, 63104
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Vero Beach, Florida, 32960
Pfizer Investigational Site
Virginia Beach, Virginia, 23454
Pfizer Investigational Site
Virginia Beach, Virginia, 23455
Pfizer Investigational Site
Voorhees Township, New Jersey, 08043
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
Pfizer Investigational Site
Washington D.C., District of Columbia, 20037
Pfizer Investigational Site
Wellesley Hills, Massachusetts, 02481-2106
Pfizer Investigational Site
Westminster, Maryland, 21157
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103-3315
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Woodbury, New Jersey, 08096
About this study
Official title: Clinical Utility Of Caduet In Simultaneously Achieving Blood Pressure And Lipid Endpoints In A Specific Patient Population (CAPABLE)
The purpose is to demonstrate the utility of Caduet (amlodipine/atorvastatin) in the African American population
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- Amlodipine/Atorvastatin
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine/AtorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of Caduet therapy by assessing the percentage of intent-to-treat subjects achieving both BP and lipid treatment goals (JNC VII and NCEP ATP III)
Secondary outcomes (1)
To assess the percentage of subjects achieving treatment goals(JNC VII and NCEP) stratified by the final BP and lipid therapy doses, respectively, the change from baseline in lipid profile, SBP and DBP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJul 2004
- Study completionAug 2005
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150384
- Sponsor's protocol ID
- A3841025
- Acronym
- CAPABLE
- Status last verified
- Jan 2021
- First submitted
- 6 Sep 2005
- 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
- Clinical Utility Of Caduet In Simultaneously Achieving Blood Pressure And Lipid Endpoints In A Specific Patient Population (CAPABLE)
- ClinicalTrials.gov ID
- NCT00150384
- Acronym / sponsor ID
- CAPABLE / A3841025
- Conditions
- Hypertension, Dyslipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Aug 2005 (actual)
- First posted
- 8 Sep 2005 (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 is to demonstrate the utility of Caduet (amlodipine/atorvastatin) in the African American population
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- African American men and women with concurrent hypertension and dyslipidemia that is either treated or untreated
- Subjects must satisfy the blood pressure and LDL-C inclusion criteria for their respective Cardiovascular Risk group determined at screening
Key exclusion criteria (2 listed)
- Subjects currently being treated with concomitant amlodipine and atorvastatin therapy, including Caduet
- Subjects with blood pressure at goal
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 |
|---|---|---|
| Amlodipine/Atorvastatin | Drug | – |
Primary outcome
To evaluate the efficacy of Caduet therapy by assessing the percentage of intent-to-treat subjects achieving both BP and lipid treatment goals (JNC VII and NCEP ATP III)
1 secondary outcome
To assess the percentage of subjects achieving treatment goals(JNC VII and NCEP) stratified by the final BP and lipid therapy doses, respectively, the change from baseline in lipid profile, SBP and DBP
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.
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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
106 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 Amlodipine/Atorvastatin in people with Hypertension and Dyslipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 106 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 106 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?
To evaluate the efficacy of Caduet therapy by assessing the percentage of intent-to-treat subjects achieving both BP and lipid treatment goals (JNC VII and NCEP ATP III). 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 8 Nov 2026.