HypertensionPhase 4NCT00669435
Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis
A Phase 4 study testing Losartan + Simvastatin and Amlodipine + Simvastatin in people with Hypertension, run by University of Pavia at 1 site in Italy.
Trial summary
Angiotensin II has been proposed as a lipid metabolism regulator. It is known that adipocytes secrete a variety of protein, such as TNFα, plasminogen activator inhibitor (PAI)-1, leptin, resistin and adiponectin; these proteins have a wide range of biological effects and are associated with insulin resistance. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Losartan + Simvastatin and Amlodipine + Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2008to Apr 2009
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: 50% Male and 50% female
- Age: 40-80 years
- Race: Caucasian
- Overweight or obese: respectively BMI25-30 kg/m2 or BMI > 30 kg m2
- Hypertensive: PA > 140/90 mmHg
- Normocholesterolemic (LDL< 160 mg/dl HDL > 35 mg/dl)
- Liver steatosis
Who cannot join
- other antihypertensive treatment after wash out period of 2 weeks
- abnormal heart rest function (EF < 55%).
- valvular heart disease
- congenital heart disease
- heart failure or prior myocardial infarction
- diabetes
Show all 13Show fewer
- renal disease
- liver disease
- connective tissue disease
- pregnancy or lactation
- serious adverse experience
- sensitivity to the study drugs or its components
- contraindication from an approved label
Trial locations and contacts
1 site in 1 country.
Giuseppe Derosa contact
Italy1 site, 1 recruiting
- Recruiting
University of Pavia
Pavia
Giuseppe Derosa, MD, 39-038-250-2614
About this study
Official title: Ultrasonographic Modification of Liver Steatosis and Visceral Fat Induced by Treatment With Losartan and Simvastatin in Hypertensive Normocholesterolemic Obese Patients
Angiotensin II has been proposed as a lipid metabolism regulator. It is known that adipocytes secrete a variety of protein, such as TNFα, plasminogen activator inhibitor (PAI)-1, leptin, resistin and adiponectin; these proteins have a wide range of biological effects and are associated with insulin resistance. Adipocytes also produce angiotensinogen and angiotensin II and a local renin-angiotensin system (RAS) is present in adipose tissue. In overweight or obese hypertensive normocholesterolemic patients the treatment with AT1-receptor blocker (Losartan) may have a better effect on hepatic steatosis and visceral fat deposition than the antihypertensive treatment with calcium channel blocker (amlodipine). Simvastatin will be added to both groups. The aim of this study is to evaluate the effect of losartan and simvastatin on ultrasonographic qualitative and quantitative parameters in overweight or obese hypertensive normocholesterolemic patients with hepatic steatosis.
- Conditions
- Hypertension
- Being tested
- Losartan + Simvastatin, Amlodipine + Simvastatin
- Keywords
- Essential hypertension, Liver steatosis
- Medical subject headings
- Hypertension, Essential Hypertension, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan + SimvastatinDrug
tablets; 50, 100 mg; od; 12 months
tablets; 20 mg; od; 6 months
Amlodipine + SimvastatinDrug
tablets; 5, 10 mg; od; 12 months
tablets; 20 mg; od; 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Amlodipine and Simvastatin Receives: Drug: Amlodipine + Simvastatin |
| 2 | Experimental | Losartan and Simvastatin Receives: Drug: Losartan + Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
All patients will undergo anthropometric evaluation and abdominal ultrasonography (performed by the same examiner); will be taken routine liver US and US measurement of visceral and subcutaneous fat.
Measured: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months
Secondary outcomes (1)
Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR
Measured: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2008
- Study completionApr 2009 (estimated)
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669435
- Sponsor's protocol ID
- UNIPV003DIM2008
- Status last verified
- Apr 2008
- First submitted
- 25 Apr 2008
- Last updated
- 30 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Modification of Liver Steatosis and Visceral Fat Induced by Treatment With Losartan and Simvastatin in Hypertensive Normocholesterolemic Obese Patients
- ClinicalTrials.gov ID
- NCT00669435
- Acronym / sponsor ID
- UNIPV003DIM2008
- Conditions
- Hypertension
- Keywords
- Essential hypertension, Liver steatosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2009 (estimated)
- First posted
- 30 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.
Angiotensin II has been proposed as a lipid metabolism regulator. It is known that adipocytes secrete a variety of protein, such as TNFα, plasminogen activator inhibitor (PAI)-1, leptin, resistin and adiponectin; these proteins have a wide range of biological effects and are associated with insulin resistance. Adipocytes also produce angiotensinogen and angiotensin II and a local renin-angiotensin system (RAS) is present in adipose tissue. In overweight or obese hypertensive normocholesterolemic patients the treatment with AT1-receptor blocker (Losartan) may have a better effect on hepatic steatosis and visceral fat deposition than the antihypertensive treatment with calcium channel blocker (amlodipine). Simvastatin will be added to both groups. The aim of this study is to evaluate the effect of losartan and simvastatin on ultrasonographic qualitative and quantitative parameters in overweight or obese hypertensive normocholesterolemic patients with hepatic steatosis.
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 + SimvastatinAmlodipine and Simvastatin |
| 2 | Experimental | Drug: Losartan + SimvastatinLosartan and Simvastatin |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Gender: 50% Male and 50% female
- Age: 40-80 years
- Race: Caucasian
- Overweight or obese: respectively BMI25-30 kg/m2 or BMI > 30 kg m2
- Hypertensive: PA > 140/90 mmHg
Key exclusion criteria (13 listed)
- other antihypertensive treatment after wash out period of 2 weeks
- abnormal heart rest function (EF < 55%).
- valvular heart disease
- congenital heart disease
- heart failure or prior myocardial infarction
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 |
|---|---|---|
| Losartan + Simvastatintablets; 50, 100 mg; od; 12 months tablets; 20 mg; od; 6 months | Drug | 2 |
| Amlodipine + Simvastatintablets; 5, 10 mg; od; 12 months tablets; 20 mg; od; 6 months | Drug | 1 |
Primary outcome
All patients will undergo anthropometric evaluation and abdominal ultrasonography (performed by the same examiner); will be taken routine liver US and US measurement of visceral and subcutaneous fat.
Time frame: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months
1 secondary outcome
Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR
Time frame: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2008.
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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.
Giuseppe Derosa contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Losartan + Simvastatin and Amlodipine + Simvastatin in people with Hypertension, run by University of Pavia at 1 site in Italy.
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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 30 Apr 2008. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Derosa (39-038-250-2614), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All patients will undergo anthropometric evaluation and abdominal ultrasonography (performed by the same examiner); will be taken routine liver US and US measurement of visceral and subcutaneous fat. (time frame: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months). 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 30 Apr 2008.