HypertensionPhase 4NCT00174330
Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia
A Phase 4 study testing atorvastatin and amlodipine in people with Hypertension and Hyperlipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 15 sites in China.
Trial summary
To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Hyperlipidemia
- What is being tested?
- atorvastatin and amlodipine
- How many people
- 330 participants
- Where
- 15 sitesChina
- Study dates
- May 2005to Feb 2006
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a diagnosis of both hyperlipidemia and hypertension.
Who cannot join
- Subjects with Type 1 diabetes mellitus or Type 2 diabetes mellitus.
- Subjects with other atherosclerotic disease.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Pfizer Investigational Site
Beijing, Beijing Municipality, 100044
Pfizer Investigational Site
Beijing, 100029
Pfizer Investigational Site
Beijing, 100083
Pfizer Investigational Site
Beijing
Pfizer Investigational Site
Guangzhou, Guangdong, 510080
Pfizer Investigational Site
Guangzhou, Guangdong, 510100
Pfizer Investigational Site
Guangzhou, Guangdong, 510515
Pfizer Investigational Site
Hangzhou, Zhejiang, 310016
Pfizer Investigational Site
Nanjing, Jiangsu, 210029
Pfizer Investigational Site
Shanghai, Shanghai Municipality, 200032
Pfizer Investigational Site
Shanghai, 200003
Pfizer Investigational Site
Shanghai, 200025
Pfizer Investigational Site
Shanghai, 200233
Pfizer Investigational Site
Shenyang, Liaoning, 110016
Pfizer Investigational Site
Tianjin, 300211
About this study
Official title: A Multi-Center, Randomized, Open-Label Study To Evaluate Efficacy And Safety Of Dual Therapy With Atorvastatin Plus Amlodipine When Compared Amlodipine Therapy Alone In The Treatment Of Subjects With Concurrent Hyperlipidemia And Hypertension.
To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- atorvastatin, amlodipine
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
amlodipineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate efficacy of the dual therapy of atorvastatin 10mg or 20mg + amlodipine 5mg or 10mg vs. amlodipine 5mg or 10mg alone
Secondary outcomes (1)
To provide comparative evaluation of the safety profile of the dual therapy with atorvastatin + amlodipine versus amlodipine alone.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2005
- Study completionFeb 2006
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
- None (open label)
- Enrolment
- 330 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
- NCT00174330
- Sponsor's protocol ID
- A3841026
- Status last verified
- Jan 2021
- First submitted
- 9 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
- A Multi-Center, Randomized, Open-Label Study To Evaluate Efficacy And Safety Of Dual Therapy With Atorvastatin Plus Amlodipine When Compared Amlodipine Therapy Alone In The Treatment Of Subjects With Concurrent Hyperlipidemia And Hypertension.
- ClinicalTrials.gov ID
- NCT00174330
- Acronym / sponsor ID
- A3841026
- Conditions
- Hypertension, Hyperlipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Feb 2006
- First posted
- 15 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.
To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with a diagnosis of both hyperlipidemia and hypertension.
Key exclusion criteria (2 listed)
- Subjects with Type 1 diabetes mellitus or Type 2 diabetes mellitus.
- Subjects with other atherosclerotic disease.
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 |
|---|---|---|
| atorvastatin | Drug | – |
| amlodipine | Drug | – |
Primary outcome
To evaluate efficacy of the dual therapy of atorvastatin 10mg or 20mg + amlodipine 5mg or 10mg vs. amlodipine 5mg or 10mg alone
1 secondary outcome
To provide comparative evaluation of the safety profile of the dual therapy with atorvastatin + amlodipine versus amlodipine alone.
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
15 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 atorvastatin and amlodipine in people with Hypertension and Hyperlipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 15 sites in China.
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 1 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 15 sites in China. 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 efficacy of the dual therapy of atorvastatin 10mg or 20mg + amlodipine 5mg or 10mg vs. amlodipine 5mg or 10mg alone. 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.