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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01360710




Registration number
NCT01360710
Ethics application status
Date submitted
24/05/2011
Date registered
26/05/2011
Date last updated
3/02/2012

Titles & IDs
Public title
The Effect of Moxonidine on Blood Pressure and Regression of Early Target Organ Damage in Young Subjects With Abdominal Obesity and Hypertension
Scientific 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
Secondary ID [1] 0 0
Young obese hypertension
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Obesity 0 0
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Moxonidine
Treatment: Drugs - Irbesartan

Experimental: Moxonidine -

Active Comparator: Irbesartan -


Treatment: Drugs: Moxonidine
0.2mg/day for 2 weeks, 0.4mg/day for 6 months

Treatment: Drugs: Irbesartan
75 mg/day for 2 weeks and then 150 mg/day for 24 weeks.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
30 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- history of cardiovascular disease, depression or anxiety disorder

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
BakerIDI Heart and Diabetes Institute - Prahran
Recruitment postcode(s) [1] 0 0
3004 - Prahran

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01360710
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Markus Schlaich
Address 0 0
Country 0 0
Phone 0 0
03 8532 1502
Fax 0 0
Email 0 0
markus.schlaich@bakeridi.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01360710