Abdominal ObesityPhase 4NCT01360710
The Effect of Moxonidine on Blood Pressure and Regression of Early Target Organ Damage in Young Subjects With Abdominal Obesity and Hypertension
A Phase 4 study testing Moxonidine and Irbesartan in people with Abdominal Obesity and Hypertension, run by Baker Heart and Diabetes Institute at 1 site in Australia.
Trial summary
Obesity is a major risk factor for the development of hypertension. Based on population studies, risk estimates indicate that at least two-thirds of the prevalence of hypertension can be directly attributed to obesity. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- Abdominal Obesity, Hypertension
- What is being tested?
- Moxonidine and Irbesartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2012to Jan 2014
- 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 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- male age 18-30 years old
- presence of central obesity and hypertension
- no history of cardiovascular disease or depression
- not on any medication
Who cannot join
- history of cardiovascular disease, depression or anxiety disorder
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
BakerIDI Heart and Diabetes Institute
Prahran, Victoria, 3004
Markus Schlaich, markus.schlaich@bakeridi.edu.au
About this study
Official title: The Effect of Moxonidine and Regression of Early Target Organ Damage in Young Subjects With Abdominal Obesity and Hypertension: a Randomised, Double Blind, Active Comparator Clinical Trial
Obesity is a major risk factor for the development of hypertension. Based on population studies, risk estimates indicate that at least two-thirds of the prevalence of hypertension can be directly attributed to obesity. Obesity per se is commonly associated with activation of the sympathetic nervous system with a predominant increase in sympathetic outflow to the kidneys and the peripheral vasculature and there is now conclusive evidence that heightened sympathetic nerve activity is a major contributor to the elevation in blood pressure associated with obesity, particularly in young subjects. In line with these findings, dietary weight loss has repeatedly been demonstrated to result in reduced sympathetic nerve activity and lower blood pressure levels.
Several lines of evidence have well documented the significant role of SNS activation in obesity associated hypertension and target organ damage. Weight loss is the preferred treatment option for obesity and its consequences and reduces both SNS activation and blood pressure. In the real world however, weight loss maintenance is rarely achieved in obese patients highlighting the urgent need for alternative treatment strategies. Given the crucial involvement of SNS activation in various aspects of the obesity related increase in blood pressure, target organ damage and cardiovascular risk, the use of sympatho-inhibitory agents at an early stage is an obvious choice.
Read more
The investigators therefore plan to examine the effects of the centrally sympatholytic agent moxonidine on blood pressure and the morning surge in blood pressure, sympathetic activity, regression of early target organ damage (heart, kidney and endothelium), metabolic and inflammatory markers in young obese subjects with hypertension in a randomized, double-blind clinical trial with the angiotensin receptor blocker irbesartan as an active comparator to achieve similar blood pressure reductions in both groups. The investigators hypothesize that moxonidine treatment will result in significant improvements in these outcome parameters and beneficial effects beyond simple blood pressure reduction.
Findings from this study could pave the way for an early and pathophysiology- tailored treatment strategy of obesity related hypertension and its detrimental consequences.
- Conditions
- Abdominal Obesity, Hypertension
- Being tested
- Moxonidine, Irbesartan
- Keywords
- male age 18-30 years old, presence of central obesity, no history of cardiovascular disease, depression, not on any medication
- Medical subject headings
- Obesity, Abdominal, Hypertension, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxonidineDrug
Also called Brand name = Physiotens
0.2mg/day for 2 weeks, 0.4mg/day for 6 months
IrbesartanDrug
75 mg/day for 2 weeks and then 150 mg/day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Moxonidine | Experimental | Not described Receives: Drug: Moxonidine |
| Irbesartan | Active comparator | Not described Receives: Drug: Irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microneurography (nerve recording)
Microneurography technique will be performed on participants at baseline and 6 months post treatment to see if moxonidine has any effect in the reduction of sympathetic activiry.
Measured: 6 months
Secondary outcomes (1)
Blood test
Blood samples will be taken from antecubital vein for biochemical analyses purposes. The sampling will take place at baseline and at 6 months visit.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal ObesityStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baker Heart and Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Schlaich, Baker Heart and Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360710
- Sponsor's protocol ID
- Young obese hypertension
- Status last verified
- Feb 2012
- First submitted
- 24 May 2011
- Last updated
- 3 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Moxonidine and Regression of Early Target Organ Damage in Young Subjects With Abdominal Obesity and Hypertension: a Randomised, Double Blind, Active Comparator Clinical Trial
- ClinicalTrials.gov ID
- NCT01360710
- Acronym / sponsor ID
- Young obese hypertension
- Conditions
- Abdominal Obesity, Hypertension
- Keywords
- male age 18-30 years old, presence of central obesity, no history of cardiovascular disease, depression, not on any medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baker Heart and Diabetes InstituteUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- First posted
- 26 May 2011 (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.
Obesity is a major risk factor for the development of hypertension. Based on population studies, risk estimates indicate that at least two-thirds of the prevalence of hypertension can be directly attributed to obesity. Obesity per se is commonly associated with activation of the sympathetic nervous system with a predominant increase in sympathetic outflow to the kidneys and the peripheral vasculature and there is now conclusive evidence that heightened sympathetic nerve activity is a major contributor to the elevation in blood pressure associated with obesity, particularly in young subjects. In line with these findings, dietary weight loss has repeatedly been demonstrated to result in reduced sympathetic nerve activity and lower blood pressure levels.
Several lines of evidence have well documented the significant role of SNS activation in obesity associated hypertension and target organ damage. Weight loss is the preferred treatment option for obesity and its consequences and reduces both SNS activation and blood pressure. In the real world however, weight loss maintenance is rarely achieved in obese patients highlighting the urgent need for alternative treatment strategies. Given the crucial involvement of SNS activation in various aspects of the obesity related increase in blood pressure, target organ damage and cardiovascular risk, the use of sympatho-inhibitory agents at an early stage is an obvious choice.
The investigators therefore plan to examine the effects of the centrally sympatholytic agent moxonidine on blood pressure and the morning surge in blood pressure, sympathetic activity, regression of early target organ damage (heart, kidney and endothelium), metabolic and inflammatory markers in young obese subjects with hypertension in a randomized, double-blind clinical trial with the angiotensin receptor blocker irbesartan as an active comparator to achieve similar blood pressure reductions in both groups. The investigators hypothesize that moxonidine treatment will result in significant improvements in these outcome parameters and beneficial effects beyond simple blood pressure reduction.
Findings from this study could pave the way for an early and pathophysiology- tailored treatment strategy of obesity related hypertension and its detrimental consequences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxonidine | Experimental | Drug: Moxonidine |
| Irbesartan | Active comparator | Drug: Irbesartan |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male age 18-30 years old
- presence of central obesity and hypertension
- no history of cardiovascular disease or depression
- not on any medication
Key exclusion criteria (1 listed)
- history of cardiovascular disease, depression or anxiety disorder
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 |
|---|---|---|
| MoxonidineAlso: Brand name = Physiotens0.2mg/day for 2 weeks, 0.4mg/day for 6 months | Drug | Moxonidine |
| Irbesartan75 mg/day for 2 weeks and then 150 mg/day for 24 weeks. | Drug | Irbesartan |
Primary outcome
Microneurography (nerve recording)
Time frame: 6 months
Microneurography technique will be performed on participants at baseline and 6 months post treatment to see if moxonidine has any effect in the reduction of sympathetic activiry.
1 secondary outcome
Blood test
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
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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.
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 Moxonidine and Irbesartan in people with Abdominal Obesity and Hypertension, run by Baker Heart and Diabetes Institute at 1 site in Australia.
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 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: status not confirmed, as of the sponsor's last update on 3 Feb 2012. 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 Australia. 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 Markus Schlaich (03 8532 1502, markus.schlaich@bakeridi.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microneurography (nerve recording) (time frame: 6 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 3 Feb 2012.