Arterial HypertensionPhase 4COMPOSERNCT04023565
Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome
A Phase 4 study testing perindopril + moxonidine in people with Arterial Hypertension and Metabolic Syndrome, run by Sergey V. Nedogoda at 1 site in Russia.
Trial summary
The aim of study is to assess the angioprotective effects of antihypertensive combination therapy with perindopril 10 mg and moxonidine 0.4-0.6 mg in patients with arterial hypertension, metabolic syndrome, and obesity, who had Pulse Wave Velocity (PWV) > 10 m/s on the previously administered two-component combination… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arterial Hypertension, Metabolic Syndrome
- What is being tested?
- perindopril + moxonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 11 Mar 2019to 30 Dec 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (male and female) aging 18 to 70 years.
- Grade 1, 2 AH (SBP 140-179 mm Hg and/or DBP 90-109 mm Hg according 2018 ESH/ESC guidelines)
- PWV > 10 m/s
- Previous two-component antihypertensive therapy (ACEi/ARB+ diuretic (HCTZ or indapamide) or ACEI/ARB + amlodipine) during at least 6 months prior to the study enrollment
- Metabolic syndrome diagnosed by the 2009 Russian Society of Cardiology (RSC) National Guidelines criteria
- THE MAIN SIGN: central (abdominal) obesity defined as waist circumference (WC) above 80 cm in women and above 94 cm in men.
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- ADDITIONAL CRITERIA:
- - arterial hypertension (BP ≥ 130/85 mm Hg) ii. - high triglycerides (≥ 1.7 mmol/l) iii. - decreased HDL-cholesterol (<1.0 mmol/l for men; <1.2 mmol/l for women) iv. - increased LDL-cholesterol > 3.0 mmol/l v. - fasting hyperglycaemia (fasting plasma glucose ≥ 6.1 mmol/l) vi. - impaired glucose tolerance (plasma glucose at 2 hours after glucose load from ≥7.8 to ≤11.1 mmol/l)
- Metabolic syndrome is defined as presence of central obesity and two of the additional criteria.
- Body Mass Index (BMI) >30 kg/m2.
- For female patients with childbearing potential: negative pregnancy test and willingness to use reliable methods of contraception until the study treatment completion
- Voluntarily signed informed consent to participate in the study.
Who cannot join
- Contraindications for using ACEi and imidazoline receptor agonists.
- Administration of perindopril or moxonidine during 6 months before the study onset.
- Metformin therapy for prophylaxis diabetes mellitus type 2 in patients with pre-diabetes, which had been started within 6 months before the study enrollment. (If a patient receives metformin for a long time, i.e., more than 6 months, he/she can be included in the study, and metformin discontinuation is not required).
- Statin and/or fibrate therapy started within 6 months before the study enrollment. (If a patient receives statins and/or fibrates for a long time, i.e., more than 6 months, he/she can be included in the study, and discontinuation of statins and fibrates is not required).
- Current diagnosis of unstable angina, acute and subacute myocardial infarction.
- Heart failure of any functional class.
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- Grade 3 AH (≥ 180/110 mm Hg).
- Sinus bradycardia (heart rate ≤50/min).
- Type 1 or 2 diabetes mellitus.
- Severe comorbidities, including mental diseases.
- Acute conditions (infections, exacerbation of chronic diseases, injuries, surgical interventions).
- Alcohol abuse.
- Pregnancy and lactation.
- Serious renal dysfunction (Estimated Glomerular Filtration Rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) ≤30 ml/min/1.73 m2).
- Serious hepatic dysfunction
- Malignancies diagnosed and treated during the previous 5 years prior to study enrollment.
- Inability to understand the study and to give informed consent for participation in it.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Dept. of Therapy and Endocrinology
Volgograd, 400131
Sergey V. Nedogoda, Professor, +79023643226, nedogodasv@rambler.ru
About this study
Official title: Open-Label Non-Comparative Study of the Effects of a Combination Antihypertensive Treatment With Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome
The aim of study is to assess the angioprotective effects of antihypertensive combination therapy with perindopril 10 mg and moxonidine 0.4-0.6 mg in patients with arterial hypertension, metabolic syndrome, and obesity, who had Pulse Wave Velocity (PWV) > 10 m/s on the previously administered two-component combination antihypertensive therapy.
Open-label non-comparative prospective study for 24 week for each patient.
Read the detailed description
According to European Society of Cardiology (ESC) and the European Society of Hypertension (ESH) Guidelines for the management of arterial hypertension 2018 in case of previous combination at full dose does not allow to achieve the target Blood Pressure (BP), that therapy might be switch to different two-drug combination.
The study will enroll 120 hypertensive (Grade 1, 2 Arterial Hypertension (AH): Systolic Blood Pressure (SBP) 140-179 mm Hg and Diastolic Blood Pressure (DBP) 90-109 mm Hg According to ESC/ESH Guidelines 2018) patients with metabolic syndrome who met the inclusion criteria when treated with Angiotensin Converting Enzyme Inhibition(ACEi) /Angiotensin Receptor Blocker (ARB) + hydrochlorothiazide (HCTZ)/indapamide or +amlodipine (30 patients in each group):
- ACEi (except perindopril) + diuretic (HCTZ or indapamide)
- ACEi (except perindopril) + amlodipine
- ARB+ diuretic (HCTZ or indapamide)
- ARB+ amlodipine
Upon obtaining Inform Consent the previous therapy will be discontinued according to recommendations (gradually or at once).
After 14 days of wash-out period perindopril 10 mg + moxonidine 0.4 mg a day will be prescribed.
If target BP is not achieved after 4 weeks, the dosage will increase up to perindopril 10 mg + moxonidine 0.6 mg a day (given as two divided doses).
FORBIDDEN TREATMENTS:
Any other antihypertensives (calcium antagonists, β-blockers, ACEi except perindopril, ARBs, diuretics) for routine AH management (except those used to resolve the uncontrolled hypertension).
CRITERIA FOR PREMATURE PATIENT WITHDRAWAL FROM THE STUDY:
- Withdrawal of informed consent by the patient at any time of the study.
- Need for uncontrolled hypertension management occurring more than 2 times weekly throughout the 2 consecutive weeks during study period.
- Need for the third antihypertensive drug.
- Conditions
- Arterial Hypertension, Metabolic Syndrome
- Being tested
- perindopril + moxonidine
- Keywords
- perindopril, moxonidine
- Medical subject headings
- Hypertension, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perindopril + moxonidineDrug
After 14 days of wash-out period perindopril 10 mg + moxonidine 0.4 mg a day will be prescribed.
If target BP is achieved after 4 weeks, the dosage will remain unchanged (perindopril 10 mg + moxonidine 0.4 mg a day (given as two divided doses).
If target BP is not achieved after 4 weeks, the dosage will increase up to perindopril 10 mg + moxonidine 0.6 mg a day (given as two divided doses).
| Study group | Role | What they receive |
|---|---|---|
| perindopril + moxonidine | Experimental | perindopril 10 mg + moxonidine 0.4 or 0.6 mg a day (given as two divided doses). Receives: Drug: perindopril + moxonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulse wave velocity (PWV)
To assess the PWV after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level.
Measured: baseline and 24 weeks
Change in Central Blood Pressure (BP)
To assess the central BP changes (systolic BP, aortic pulse BP) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline levels.
Measured: baseline and 24 weeks
Change in Reflected wave index
To assess the reflected wave index after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level.
Measured: baseline and 24 weeks
Secondary outcomes (6)
Change in carbohydrate and lipid metabolism parameters markers
To assess the homeostatic model assessment - insulin resistance (HOMA-IR), and lipid metabolism (total cholesterol, triglycerides, low-density lipoprotein (LDL), high-density lipoprotein (HDL)) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline levels.
Measured: baseline and 24 weeks
Change in the adipokine level
To assess the adipokine level (leptin) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level.
Measured: baseline and 24 weeks
Change in the Inflammatory marker level
To assess the high sensible C-reactive Protein (hs-CRP) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level.
Measured: baseline and 24 weeks
Change in the renin-angiotensin-aldosterone system hyperactivation marker level
To assess the renin-angiotensin-aldosterone system hyperactivation marker level (plasma aldosterone-to-renin ratio) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level
Measured: baseline and 24 weeks
Change in the sympathoadrenal system hyperactivation marker levels
To assess the sympathoadrenal system hyperactivation marker levels (urine excretion adrenaline, noradrenaline, dofamine levels) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline levels.
Measured: baseline and 24 weeks
Proportion of patients achieved target BP level
To assess the proportion of patients (%) achieving target BP levels <130/80 mm Hg at Week 4, Week 12, Week 24
Measured: Week 4, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start11 Mar 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sergey V. Nedogoda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sergey V. Nedogoda, Volgograd State Medical University
- Investigators
- Sergey V. Nedogoda, Professor, Principal investigator, Volgograd State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023565
- Sponsor's protocol ID
- MOXOD001
- Acronym
- COMPOSER
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Non-Comparative Study of the Effects of a Combination Antihypertensive Treatment With Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT04023565
- Acronym / sponsor ID
- COMPOSER / MOXOD001
- Conditions
- Arterial Hypertension, Metabolic Syndrome
- Keywords
- perindopril, moxonidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sergey V. NedogodaUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 17 Jul 2019 (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.
The aim of study is to assess the angioprotective effects of antihypertensive combination therapy with perindopril 10 mg and moxonidine 0.4-0.6 mg in patients with arterial hypertension, metabolic syndrome, and obesity, who had Pulse Wave Velocity (PWV) > 10 m/s on the previously administered two-component combination antihypertensive therapy.
Open-label non-comparative prospective study for 24 week for each patient.
Detailed description
According to European Society of Cardiology (ESC) and the European Society of Hypertension (ESH) Guidelines for the management of arterial hypertension 2018 in case of previous combination at full dose does not allow to achieve the target Blood Pressure (BP), that therapy might be switch to different two-drug combination.
The study will enroll 120 hypertensive (Grade 1, 2 Arterial Hypertension (AH): Systolic Blood Pressure (SBP) 140-179 mm Hg and Diastolic Blood Pressure (DBP) 90-109 mm Hg According to ESC/ESH Guidelines 2018) patients with metabolic syndrome who met the inclusion criteria when treated with Angiotensin Converting Enzyme Inhibition(ACEi) /Angiotensin Receptor Blocker (ARB) + hydrochlorothiazide (HCTZ)/indapamide or +amlodipine (30 patients in each group):
- ACEi (except perindopril) + diuretic (HCTZ or indapamide)
- ACEi (except perindopril) + amlodipine
- ARB+ diuretic (HCTZ or indapamide)
- ARB+ amlodipine
Upon obtaining Inform Consent the previous therapy will be discontinued according to recommendations (gradually or at once).
After 14 days of wash-out period perindopril 10 mg + moxonidine 0.4 mg a day will be prescribed.
If target BP is not achieved after 4 weeks, the dosage will increase up to perindopril 10 mg + moxonidine 0.6 mg a day (given as two divided doses).
FORBIDDEN TREATMENTS:
Any other antihypertensives (calcium antagonists, β-blockers, ACEi except perindopril, ARBs, diuretics) for routine AH management (except those used to resolve the uncontrolled hypertension).
CRITERIA FOR PREMATURE PATIENT WITHDRAWAL FROM THE STUDY:
- Withdrawal of informed consent by the patient at any time of the study.
- Need for uncontrolled hypertension management occurring more than 2 times weekly throughout the 2 consecutive weeks during study period.
- Need for the third antihypertensive drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| perindopril + moxonidine | Experimental | Drug: perindopril + moxonidineperindopril 10 mg + moxonidine 0.4 or 0.6 mg a day (given as two divided doses). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients (male and female) aging 18 to 70 years.
- Grade 1, 2 AH (SBP 140-179 mm Hg and/or DBP 90-109 mm Hg according 2018 ESH/ESC guidelines)
- PWV > 10 m/s
- Previous two-component antihypertensive therapy (ACEi/ARB+ diuretic (HCTZ or indapamide) or ACEI/ARB + amlodipine) during at least 6 months prior to the study enrollment
- Metabolic syndrome diagnosed by the 2009 Russian Society of Cardiology (RSC) National Guidelines criteria
Key exclusion criteria (17 listed)
- Contraindications for using ACEi and imidazoline receptor agonists.
- Administration of perindopril or moxonidine during 6 months before the study onset.
- Metformin therapy for prophylaxis diabetes mellitus type 2 in patients with pre-diabetes, which had been started within 6 months before the study enrollment. (If a patient receives metformin for a long time, i.e., more than 6 months, he/she can be included in the study, and metformin discontinuation is not required).
- Statin and/or fibrate therapy started within 6 months before the study enrollment. (If a patient receives statins and/or fibrates for a long time, i.e., more than 6 months, he/she can be included in the study, and discontinuation of statins and fibrates is not required).
- Current diagnosis of unstable angina, acute and subacute 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 |
|---|---|---|
| perindopril + moxonidineAfter 14 days of wash-out period perindopril 10 mg + moxonidine 0.4 mg a day will be prescribed. If target BP is achieved after 4 weeks, the dosage will remain unchanged (perindopril 10 mg + moxonidine 0.4 mg a day (given as two divided doses). If target BP is not achieved after 4 weeks, the dosage will increase up to perindopril 10 mg + moxonidine 0.6 mg a day (given as two divided doses). | Drug | perindopril + moxonidine |
Primary outcome
Change in Pulse wave velocity (PWV)
Time frame: baseline and 24 weeks
To assess the PWV after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level.
Change in Central Blood Pressure (BP)
Time frame: baseline and 24 weeks
To assess the central BP changes (systolic BP, aortic pulse BP) after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline levels.
Change in Reflected wave index
Time frame: baseline and 24 weeks
To assess the reflected wave index after 24 weeks of combination treatment with perindopril 10 mg and moxonidine 0.4-0.6 mg against baseline level.
6 secondary outcomes
Change in carbohydrate and lipid metabolism parameters markers
Time frame: baseline and 24 weeks
Change in the adipokine level
Time frame: baseline and 24 weeks
Change in the Inflammatory marker level
Time frame: baseline and 24 weeks
Change in the renin-angiotensin-aldosterone system hyperactivation marker level
Time frame: baseline and 24 weeks
Change in the sympathoadrenal system hyperactivation marker levels
Time frame: baseline and 24 weeks
Proportion of patients achieved target BP level
Time frame: Week 4, Week 12, Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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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.
Sergey V. Nedogoda, Professor principal investigator
Volgograd State Medical University
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 perindopril + moxonidine in people with Arterial Hypertension and Metabolic Syndrome, run by Sergey V. Nedogoda at 1 site in Russia.
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 12 inclusion and 17 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 23 Jul 2019. 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 Russia. 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 Sergey V. Nedogoda, Professor (+79023643226, nedogodasv@rambler.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pulse wave velocity (PWV) (time frame: baseline and 24 weeks). The study lists 3 primary outcomes in all. 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 23 Jul 2019.