HypercholesterolaemiaPhase 3NCT00163163
Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
A Phase 3 study testing Echographic measurements and Blood samples in people with Hypercholesterolaemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 69 sites in 3 countries.
Trial summary
To evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid intima-media thickness in postmenopausal women with moderate hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- Echographic measurements and Blood samples
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 69 sitesin 3 countries
- Study dates
- Jan 2003to Jul 2006
- Phase
- Phase 3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women defined as having Age =< 70 years with documented menopause
- Fasting LDL cholesterol 130 mg/ dl (3.37 mmol/l)and =< 190 mg/ dl (4.92 mmol/l) after 6 weeks of diet
- Triglycerides =< 4 g/l(4.52 mmol/l)
- Informed, written consent
Who cannot join
- Age > 70 years
- Unconfirmed menopause
- Overall duration of treatment with any HMG-CoA Reductase inhibitor > 3 months within the last year
- Patient treated with any lipid-lowering drugs within the last 6 weeks preceding the randomization
- History of myocardial infarction, coronary bypass surgery, angioplasty, stroke or TIA
- CPK levels > 3 times upper limit of normal
- Body Mass Index >= 30
Trial locations and contacts
69 sites in 3 countries.
69 sites in 3 countries
France52 sites
Pfizer Investigational Site
Achenheim, 67204
Pfizer Investigational Site
Ancerville, 55170
Pfizer Investigational Site
Augny, 57685
Pfizer Investigational Site
Bar-le-Duc, 55000
Pfizer Investigational Site
Bœrsch, 67530
Pfizer Investigational Site
Bois-Colombes, 92220
Pfizer Investigational Site
Boissy-Saint-Léger, 94470
Pfizer Investigational Site
Bouzonville, 57320
Pfizer Investigational Site
Colombey-les-Belles, 54170
Pfizer Investigational Site
Dammarie-les-Lys, 77190
Pfizer Investigational Site
Docelles, 88460
Pfizer Investigational Site
Dourdan, 91410
Pfizer Investigational Site
Eckbolsheim, 67201
Pfizer Investigational Site
Epinay S/orge, 91360
Pfizer Investigational Site
Étampes, 91150
Pfizer Investigational Site
Frouard, 54390
Pfizer Investigational Site
Gambsheim, 67760
Pfizer Investigational Site
Haguenau, 67500
Pfizer Investigational Site
Kilstett, 67840
Pfizer Investigational Site
Laxou, 54520
Pfizer Investigational Site
Le Grand-Quevilly, 76120
Pfizer Investigational Site
Le Mesnil-Esnard, 76240
Pfizer Investigational Site
Leuville-sur-Orge, 91310
Pfizer Investigational Site
Lingolsheim, 67380
Pfizer Investigational Site
Longpont-sur-Orge, 91310
Pfizer Investigational Site
Mars-la-Tour, 54800
Pfizer Investigational Site
Metz, 57000
Pfizer Investigational Site
Moûtiers, 54660
Pfizer Investigational Site
Nancy, 54000
Pfizer Investigational Site
Nancy, 5400
Pfizer Investigational Site
Nancy, 54100
Pfizer Investigational Site
Paris, 75008
Pfizer Investigational Site
Paris, 75012
Pfizer Investigational Site
Paris, 75015
Pfizer Investigational Site
Paris, 75016
Pfizer Investigational Site
Paris, 75017
Pfizer Investigational Site
Pont-à-Mousson, 54700
Pfizer Investigational Site
Pulnoy, 54420
Pfizer Investigational Site
Rouen, 76100
Pfizer Investigational Site
Saint-Max, 54130
Pfizer Investigational Site
Sainte-Geneviève-des-Bois, 91700
Pfizer Investigational Site
Sauvigny, 55140
Pfizer Investigational Site
Savigny-sur-Orge, 91600
Pfizer Investigational Site
Sotteville-lès-Rouen, 76308
Pfizer Investigational Site
Souffelweyersheim, 67460
Pfizer Investigational Site
Strasbourg, 67000
Pfizer Investigational Site
Strasbourg, 67200
Pfizer Investigational Site
Terville, 57180
Pfizer Investigational Site
Toul, 54200
Pfizer Investigational Site
Vandœuvre-lès-Nancy, 54500
Pfizer Investigational Site
Verdun, 55100
Pfizer Investigational Site
Vincennes, 94300
Belgium14 sites
Pfizer Investigational Site
Afsnee GENT, 9051
Pfizer Investigational Site
Assenede, 9960
Pfizer Investigational Site
Brussels, 1030
Pfizer Investigational Site
Brussels, 1050
Pfizer Investigational Site
Brussels, 1090
Pfizer Investigational Site
Brussels, 1180
Pfizer Investigational Site
Brussels, 1190
Pfizer Investigational Site
Ertvelde, 9940
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Linkebeek, 1630
Pfizer Investigational Site
Sint-Niklaas, 9100
Pfizer Investigational Site
Tielt, 8700
Pfizer Investigational Site
Wetteren, 9230
Pfizer Investigational Site
Wondelgem, 9032
Netherlands3 sites
Pfizer Investigational Site
ED Voerendaal, 6367
Pfizer Investigational Site
EN Vaals, 6291
Pfizer Investigational Site
VE Maastricht, 6222
About this study
Official title: Carotid Atorvastatin Study In Hyperlipidemic Post-Menopausal Women: A Randomized Evaluation of Atorvastatin, Versus Placebo (CASHMERE)
To evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid intima-media thickness in postmenopausal women with moderate hypercholesterolemia.
- Conditions
- Hypercholesterolaemia
- Being tested
- Echographic measurements, Blood samples
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echographic measurementsProcedure or surgery
Blood samplesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in carotid IMT from baseline to month 12.
Secondary outcomes (4)
Mean change from baseline to month 12 of carotid internal diameter (ID)
wall cross sectional area (WCSA); carotid arterial mass (AM)
pulse pressure (PP); cross sectional distensibility and compliance (DC and CC)
pulse wave velocity (PWV); Lipid profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startJan 2003
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolaemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 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
- NCT00163163
- Sponsor's protocol ID
- A2581051
- Status last verified
- Feb 2021
- First submitted
- 9 Sep 2005
- Last updated
- 18 Feb 2021
- Results posted
- No
Publications
Gompel A, Boutouyrie P, Joannides R, Christin-Maitre S, Kearny-Schwartz A, Kunz K, Laurent S, Boivin JM, Pannier B, Pornel B, Struijker-Boudier HA, Thuillez C, Van Bortel L, Zannad F, Pithois-Merli I, Jaillon P, Simon T. Association of menopause and hormone replacement therapy with large artery remodeling. Fertil Steril. 2011 Dec;96(6):1445-50. doi: 10.1016/j.fertnstert.2011.09.010. Epub 2011 Oct 6.
PubMed 21982290
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Atorvastatin Study In Hyperlipidemic Post-Menopausal Women: A Randomized Evaluation of Atorvastatin, Versus Placebo (CASHMERE)
- ClinicalTrials.gov ID
- NCT00163163
- Acronym / sponsor ID
- A2581051
- Conditions
- Hypercholesterolaemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Jul 2006 (actual)
- First posted
- 13 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 the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid intima-media thickness in postmenopausal women with moderate hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women defined as having Age =< 70 years with documented menopause
- Fasting LDL cholesterol 130 mg/ dl (3.37 mmol/l)and =< 190 mg/ dl (4.92 mmol/l) after 6 weeks of diet
- Triglycerides =< 4 g/l(4.52 mmol/l)
- Informed, written consent
Key exclusion criteria (7 listed)
- Age > 70 years
- Unconfirmed menopause
- Overall duration of treatment with any HMG-CoA Reductase inhibitor > 3 months within the last year
- Patient treated with any lipid-lowering drugs within the last 6 weeks preceding the randomization
- History of myocardial infarction, coronary bypass surgery, angioplasty, stroke or TIA
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 |
|---|---|---|
| Echographic measurements | Procedure or surgery | – |
| Blood samples | Procedure or surgery | – |
Primary outcome
Mean change in carotid IMT from baseline to month 12.
4 secondary outcomes
Mean change from baseline to month 12 of carotid internal diameter (ID)
wall cross sectional area (WCSA); carotid arterial mass (AM)
pulse pressure (PP); cross sectional distensibility and compliance (DC and CC)
pulse wave velocity (PWV); Lipid profile
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 18 Feb 2021.
- Derived from this study: PubMed 21982290Gompel A, Boutouyrie P, Joannides R, Christin-Maitre S, Kearny-Schwartz A, Kunz K, Laurent S, Boivin JM, Pannier B, Pornel B, Struijker-Boudier HA, Thuillez C, Van Bortel L, Zannad F, Pithois-Merli I, Jaillon P, Simon T. Association of menopause and hormone replacement therapy with large artery remodeling. Fertil Steril. 2011 Dec;96(6):1445-50. doi: 10.1016/j.fertnstert.2011.09.010. Epub 2011 Oct 6.
- 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
69 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Echographic measurements and Blood samples in people with Hypercholesterolaemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 69 sites in 3 countries.
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 4 inclusion and 7 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in France, Belgium, Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mean change in carotid IMT from baseline to month 12.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00163163, which also lists 1 linked publication.
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 18 Feb 2021.