HypertensionNCT01126684
Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion
A study testing Atorvastatin in people with Hypertension and Hypercholesterolemia, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
To evaluate the possible effects of atorvastatin on ambulatory blood pressure, urinary albumin excretion, insulin resistance and arterial stiffness in hypertensive patients, beyond those on lipid profile. Glycemic parameters, "novel" cardiovascular risk factors and safety parameters will be also evaluated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Hypercholesterolemia
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2008to Dec 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LDL-C>130 or >160 mg/dL (depending on the total risk according to the most recent recommendations25).
- no previous hypolipidemic medication
- ability to provide Informed Consent.
Who cannot join
- pregnancy or lactation
- myocardial infarction or unstable angina within the past 6 months
- heart failure NYHA class III-IV
- renal disease (SCr>3 mg/dL or proteinuria>3g/d)
- liver disease
- history of malignancy
Show all 10Show fewer
- history of drug or alcohol abuse
- treatment with corticosteroids
- any other condition with poor prognosis
- inability to provide Informed Consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTS OF ATORVASTATIN ON BLOOD PRESSURE AND URINARY ALBUMIN EXCRETION IN PATIENTS WITH ESSENTIAL HYPERTENSION
To evaluate the possible effects of atorvastatin on ambulatory blood pressure, urinary albumin excretion, insulin resistance and arterial stiffness in hypertensive patients, beyond those on lipid profile. Glycemic parameters, "novel" cardiovascular risk factors and safety parameters will be also evaluated.
- Conditions
- Hypertension, Hypercholesterolemia
- Being tested
- Atorvastatin, Placebo
- Keywords
- essential hypertension
- Medical subject headings
- Hypertension, Hypercholesterolemia, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
10 mg of atorvastatin once daily for six months
PlaceboDrug
placebo once daily for six months
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | Not described Receives: Drug: Atorvastatin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure
Measured: Six months
Secondary outcomes (8)
Urinary Albumin Excretion
Measured: Six months
Insulin Sensitivity
Measured: Six months
Arterial Stiffness
Measured: Six months
Urinary levels of nephrin
Measured: Six months
Urinary levels of podocalyxin
Measured: Six months
Urinary levels of Endothelin-1
Measured: Six months
Urinary levels of Asymmetric Dimethylarginine
Measured: Six months
Urinary levels of indices of oxidative stress
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startJun 2008
- Primary completionDec 2009
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 HypertensionStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Investigators
- Anastasios Lasaridis, MD, PhD, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126684
- Sponsor's protocol ID
- STAY
- Status last verified
- Apr 2010
- First submitted
- 19 May 2010
- Last updated
- 20 May 2010
- Results posted
- No
Publications
Kanaki AI, Sarafidis PA, Georgianos PI, Kanavos K, Tziolas IM, Zebekakis PE, Lasaridis AN. Effects of low-dose atorvastatin on arterial stiffness and central aortic pressure augmentation in patients with hypertension and hypercholesterolemia. Am J Hypertens. 2013 May;26(5):608-16. doi: 10.1093/ajh/hps098. Epub 2013 Feb 28.
PubMed 23449607
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF ATORVASTATIN ON BLOOD PRESSURE AND URINARY ALBUMIN EXCRETION IN PATIENTS WITH ESSENTIAL HYPERTENSION
- ClinicalTrials.gov ID
- NCT01126684
- Acronym / sponsor ID
- STAY
- Conditions
- Hypertension, Hypercholesterolemia
- Keywords
- essential hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (actual)
- First posted
- 20 May 2010 (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 possible effects of atorvastatin on ambulatory blood pressure, urinary albumin excretion, insulin resistance and arterial stiffness in hypertensive patients, beyond those on lipid profile. Glycemic parameters, "novel" cardiovascular risk factors and safety parameters will be also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: Atorvastatin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- LDL-C>130 or >160 mg/dL (depending on the total risk according to the most recent recommendations25).
- no previous hypolipidemic medication
- ability to provide Informed Consent.
Key exclusion criteria (10 listed)
- pregnancy or lactation
- myocardial infarction or unstable angina within the past 6 months
- heart failure NYHA class III-IV
- renal disease (SCr>3 mg/dL or proteinuria>3g/d)
- liver 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 |
|---|---|---|
| Atorvastatin10 mg of atorvastatin once daily for six months | Drug | Atorvastatin |
| Placeboplacebo once daily for six months | Drug | Placebo |
Primary outcome
Ambulatory blood pressure
Time frame: Six months
8 secondary outcomes
Urinary Albumin Excretion
Time frame: Six months
Insulin Sensitivity
Time frame: Six months
Arterial Stiffness
Time frame: Six months
Urinary levels of nephrin
Time frame: Six months
Urinary levels of podocalyxin
Time frame: Six months
Urinary levels of Endothelin-1
Time frame: Six months
Urinary levels of Asymmetric Dimethylarginine
Time frame: Six months
Urinary levels of indices of oxidative stress
Time frame: Six months
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 20 May 2010.
- Derived from this study: PubMed 23449607Kanaki AI, Sarafidis PA, Georgianos PI, Kanavos K, Tziolas IM, Zebekakis PE, Lasaridis AN. Effects of low-dose atorvastatin on arterial stiffness and central aortic pressure augmentation in patients with hypertension and hypercholesterolemia. Am J Hypertens. 2013 May;26(5):608-16. doi: 10.1093/ajh/hps098. Epub 2013 Feb 28.
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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.
Anastasios Lasaridis, MD, PhD principal investigator
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin in people with Hypertension and Hypercholesterolemia, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 3 inclusion and 10 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 20 May 2010. 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 Greece. 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. Some participants in this study may receive a placebo. 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 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?
Ambulatory blood pressure (time frame: Six months). 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 NCT01126684, 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 20 May 2010.