ObesityPhase 4OHTNCT04474899
Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension
A Phase 4 study testing Moxonidine 0.4 MG and Amlodipine 5mg in people with Obesity and Hypertension, run by Royal Perth Hospital at 1 site in Australia.
Trial summary
This study is designed to investigate whether sympathoinhibition with moxonidine could provide added metabolic benefit compared to the second line therapy in the current guidelines. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Obesity, Hypertension
- What is being tested?
- Moxonidine 0.4 MG and Amlodipine 5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Jun 2015to 24 Jun 2024
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 25 -70 years
- (Body Mass Index) BMI≥30kg/m2
- Currently weight stable (+/- 3% in previous 6-12 months and not on any specific exercise or dietary program)
- Elevated clinic systolic (Blood Pressure) BP ≥135 or diastolic BP ≥85mmHg,
- on ACE inhibitor for at least 6 weeks prior to baseline assessment
Who cannot join
- Grade 2-3 hypertension (systolic office BP >160, diastolic office BP >100 mmHg)
- Secondary causes of hypertension
- CKD (Chronic kidney disease) stage 4-5 {(estimated glomerular filtration) eGFR<30ml/min}
- Heart failure NYHA (New York Heart Association) class II-IV
- Recent CV (cardiovascular) event (acute myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous six months) unstable psychiatric condition
- medication such as corticosteroids, several antidepressants and antipsychotics
- Female participants of childbearing potential must have a negative pregnancy test prior to treatment
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Dobney Hypertension Centre
Perth, Western Australia, 6155
Markus Schlaich, +61 8 92240390, markus.schlaich@uwa.edu.au
Revathy Carnagarin, +61 8 92240316, revathy.carnagarin@uwa.edu.au
About this study
This study is designed to investigate whether sympathoinhibition with moxonidine could provide added metabolic benefit compared to the second line therapy in the current guidelines.
Read the detailed description
This is a randomised, double-blind, cross-over study. Participants will be randomly assigned to receive either moxonidine 0.4mg daily or amlodipine 5mg and will later receive the alternate treatment.
Comprehensive testing will occur after each 12 week treatment phase and will include assessment of muscle sympathetic nerve activity, gut microbiome analysis and metabolic markers.
- Conditions
- Obesity, Hypertension
- Being tested
- Moxonidine 0.4 MG, Amlodipine 5mg
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxonidine 0.4 MGDrug
Participants will be randomly assigned to receive moxonidine 0.4mg/daily and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.
Amlodipine 5mgDrug
Participants will be randomly assigned to receive amlodipine 5mg and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | Moxonidine 0.4mg/daily Receives: Drug: Moxonidine 0.4 MG; Drug: Amlodipine 5mg |
| Phase 2 | Experimental | Amlodipine 5mg Receives: Drug: Moxonidine 0.4 MG; Drug: Amlodipine 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring
Measured: 30 weeks
Secondary outcomes (3)
blood glucose levels
Changes in glycemic control through oral glucose tolerance test
Measured: 30 weeks
Gut microbiota profile
Change in gut microbiota assessed by short chain fatty acid
Measured: 30 weeks
Lipid levels in blood
change in triglyceride, HDL and LDL levels in blood
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start24 Jun 2015
- Primary completion24 Feb 2024 (estimated)
- Study completion24 Jun 2024 (estimated)
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 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
- Crossover
- Model description
- Randomized, double blind cross over study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Perth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Western Australia
- Responsible party
- Principal investigator, Dr Markus Schlaich, Royal Perth Hospital
- Investigators
- Markus Schlaich, MD, Principal investigator, University of Western Australia and Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474899
- Sponsor's protocol ID
- RA-4-1-7565
- Acronym
- OHT
- Status last verified
- Sep 2022
- First submitted
- 3 Jun 2020
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared to maintain anonymity and confidentiality of the participants
Publications
Carnagarin R, Gregory C, Azzam O, Hillis GS, Schultz C, Watts GF, Bell D, Matthews V, Schlaich MP. The Role of Sympatho-Inhibition in Combination Treatment of Obesity-Related Hypertension. Curr Hypertens Rep. 2017 Oct 28;19(12):99. doi: 10.1007/s11906-017-0795-1.
PubMed 29080925
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension
- ClinicalTrials.gov ID
- NCT04474899
- Acronym / sponsor ID
- OHT / RA-4-1-7565
- Conditions
- Obesity, Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Royal Perth HospitalUniversity, hospital or other
- Collaborators
- The University of Western Australia
- Study start
- 24 Jun 2015 (actual)
- Primary completion
- 24 Feb 2024 (estimated)
- Study completion
- 24 Jun 2024 (estimated)
- First posted
- 17 Jul 2020 (actual)
- 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.
This study is designed to investigate whether sympathoinhibition with moxonidine could provide added metabolic benefit compared to the second line therapy in the current guidelines.
Detailed description
This is a randomised, double-blind, cross-over study. Participants will be randomly assigned to receive either moxonidine 0.4mg daily or amlodipine 5mg and will later receive the alternate treatment.
Comprehensive testing will occur after each 12 week treatment phase and will include assessment of muscle sympathetic nerve activity, gut microbiome analysis and metabolic markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind cross over study
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Drug: Moxonidine 0.4 MG, Drug: Amlodipine 5mgMoxonidine 0.4mg/daily |
| Phase 2 | Experimental | Drug: Moxonidine 0.4 MG, Drug: Amlodipine 5mgAmlodipine 5mg |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 25 -70 years
- (Body Mass Index) BMI≥30kg/m2
- Currently weight stable (+/- 3% in previous 6-12 months and not on any specific exercise or dietary program)
- Elevated clinic systolic (Blood Pressure) BP ≥135 or diastolic BP ≥85mmHg,
- on ACE inhibitor for at least 6 weeks prior to baseline assessment
Key exclusion criteria (7 listed)
- Grade 2-3 hypertension (systolic office BP >160, diastolic office BP >100 mmHg)
- Secondary causes of hypertension
- CKD (Chronic kidney disease) stage 4-5 {(estimated glomerular filtration) eGFR<30ml/min}
- Heart failure NYHA (New York Heart Association) class II-IV
- Recent CV (cardiovascular) event (acute myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous six months) unstable psychiatric condition
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 |
|---|---|---|
| Moxonidine 0.4 MGParticipants will be randomly assigned to receive moxonidine 0.4mg/daily and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period. | Drug | Phase 1, Phase 2 |
| Amlodipine 5mgParticipants will be randomly assigned to receive amlodipine 5mg and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period. | Drug | Phase 1, Phase 2 |
Primary outcome
Blood Pressure
Time frame: 30 weeks
Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring
3 secondary outcomes
blood glucose levels
Time frame: 30 weeks
Gut microbiota profile
Time frame: 30 weeks
Lipid levels in blood
Time frame: 30 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Background: PubMed 29080925Carnagarin R, Gregory C, Azzam O, Hillis GS, Schultz C, Watts GF, Bell D, Matthews V, Schlaich MP. The Role of Sympatho-Inhibition in Combination Treatment of Obesity-Related Hypertension. Curr Hypertens Rep. 2017 Oct 28;19(12):99. doi: 10.1007/s11906-017-0795-1.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared to maintain anonymity and confidentiality of the participants
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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.
Markus Schlaich, MD principal investigator
University of Western Australia and Royal Perth Hospital
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 0.4 MG and Amlodipine 5mg in people with Obesity and Hypertension, run by Royal Perth Hospital 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 5 inclusion and 7 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 29 Sep 2022. 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 Revathy Carnagarin, MD (+61 8 92240316, revathy.carnagarin@uwa.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 30 weeks). 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 NCT04474899, 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 29 Sep 2022.