HypertensionNCT00656331
The Pleiotropic Effects of Atorvastatin When Combined With Common Antihypertenisve Medications.
A study testing Amlodipine and Hydrocholorothiazide in people with Hypertension, run by University of New Mexico at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of the cholesterol medication taken with each blood pressure medication alone on heart disease risk factors including blood pressure, cholesterol, inflammation, blood sugar control, blood vessal function, and other heart disease risk factors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Amlodipine and Hydrocholorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jun 2012
- Phase
- Interventional
- 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
- mild hypertension and high cholesterol
Who cannot join
- diabetes and heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pleiotropic Effects of Atorvastatin When Combined With Common Antihypertenisve Medications: A Comparison of Amlodipine and Hydrochlorothiazide
The purpose of this study is to compare the effects of the cholesterol medication taken with each blood pressure medication alone on heart disease risk factors including blood pressure, cholesterol, inflammation, blood sugar control, blood vessal function, and other heart disease risk factors.
- Conditions
- Hypertension
- Being tested
- Amlodipine and Hydrocholorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine and HydrocholorothiazideDrug
Arm 1 gets Amlodipine and Arm 2 gets Hydrocholorothiazide
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Amlodipine Receives: Drug: Amlodipine and Hydrocholorothiazide |
| 2 | Active comparator | HCTZ Receives: Drug: Amlodipine and Hydrocholorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAI-1
Measured: study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startAug 2005
- Primary completionJun 2012
- Study completionJun 2012
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Colleran, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656331
- Sponsor's protocol ID
- 05-106
- Status last verified
- Jul 2023
- First submitted
- 7 Apr 2008
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pleiotropic Effects of Atorvastatin When Combined With Common Antihypertenisve Medications: A Comparison of Amlodipine and Hydrochlorothiazide
- ClinicalTrials.gov ID
- NCT00656331
- Acronym / sponsor ID
- 05-106
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Apr 2008 (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 compare the effects of the cholesterol medication taken with each blood pressure medication alone on heart disease risk factors including blood pressure, cholesterol, inflammation, blood sugar control, blood vessal function, and other heart disease risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Amlodipine and HydrocholorothiazideAmlodipine |
| 2 | Active comparator | Drug: Amlodipine and HydrocholorothiazideHCTZ |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mild hypertension and high cholesterol
Key exclusion criteria (1 listed)
- diabetes and heart 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 |
|---|---|---|
| Amlodipine and HydrocholorothiazideArm 1 gets Amlodipine and Arm 2 gets Hydrocholorothiazide | Drug | 1, 2 |
Primary outcome
PAI-1
Time frame: study completion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
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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.
Kathleen Colleran, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amlodipine and Hydrocholorothiazide in people with Hypertension, run by University of New Mexico at 1 site 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
PAI-1 (time frame: study completion). 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 11 Jul 2023.