Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

The Effect of Moxonidine on Blood Pressure and Regression of Early Target Organ Damage in Young Subjects With Abdominal Obesity and Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01360710
Recruitment Status : Unknown
Verified February 2012 by Markus Schlaich, Baker IDI Heart and Diabetes Institute.
Recruitment status was:  Recruiting
First Posted : May 26, 2011
Last Update Posted : February 3, 2012
Information provided by (Responsible Party):
Markus Schlaich, Baker IDI Heart and Diabetes Institute

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Abdominal Obesity Hypertension Drug: Moxonidine Drug: Irbesartan Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2012
Estimated Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Arm Intervention/treatment
Experimental: Moxonidine Drug: Moxonidine
0.2mg/day for 2 weeks, 0.4mg/day for 6 months
Other Name: Brand name = Physiotens

Active Comparator: Irbesartan Drug: Irbesartan
75 mg/day for 2 weeks and then 150 mg/day for 24 weeks.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Blood test [ Time Frame: 6 months ]
    Blood samples will be taken from antecubital vein for biochemical analyses purposes. The sampling will take place at baseline and at 6 months visit.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male age 18-30 years old
  • presence of central obesity and hypertension
  • no history of cardiovascular disease or depression
  • not on any medication

Exclusion Criteria:

  • history of cardiovascular disease, depression or anxiety disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01360710

Layout table for location contacts
Contact: Markus Schlaich 03 8532 1502

Layout table for location information
Australia, Victoria
BakerIDI Heart and Diabetes Institute Recruiting
Prahran, Victoria, Australia, 3004
Contact: Markus Schlaich   
Sponsors and Collaborators
Baker IDI Heart and Diabetes Institute

Layout table for additonal information
Responsible Party: Markus Schlaich, A/Prof, Baker IDI Heart and Diabetes Institute Identifier: NCT01360710    
Other Study ID Numbers: Young obese hypertension
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012
Keywords provided by Markus Schlaich, Baker IDI Heart and Diabetes Institute:
male age 18-30 years old
presence of central obesity
no history of cardiovascular disease, depression
not on any medication
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity, Abdominal
Vascular Diseases
Cardiovascular Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action