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.
Condition or disease | Intervention/treatment | Phase |
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Arterial Hypertension Metabolic Syndrome | Drug: perindopril + moxonidine | Phase 4 |
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):
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:
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-Label Non-Comparative Study of the Effects of a Combination Antihypertensive Treatment With Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome |
Actual Study Start Date : | March 11, 2019 |
Estimated Primary Completion Date : | June 30, 2020 |
Estimated Study Completion Date : | December 30, 2020 |
Arm | Intervention/treatment |
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Experimental: perindopril + moxonidine
perindopril 10 mg + moxonidine 0.4 or 0.6 mg a day (given as two divided doses).
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Drug: perindopril + moxonidine
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). |
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Metabolic syndrome diagnosed by the 2009 Russian Society of Cardiology (RSC) National Guidelines criteria
i. - 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.
Exclusion Criteria:
Contact: Sergey V. Nedogoda, Professor | +79023643226 | nedogodasv@rambler.ru |
Russian Federation | |
Dept. of Therapy and Endocrinology | Recruiting |
Volgograd, Russian Federation, 400131 | |
Contact: Sergey V. Nedogoda, Professor +79023643226 nedogodasv@rambler.ru |
Principal Investigator: | Sergey V. Nedogoda, Professor | Volgograd State Medical University |
Tracking Information | |||||||
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First Submitted Date ICMJE | July 15, 2019 | ||||||
First Posted Date ICMJE | July 17, 2019 | ||||||
Last Update Posted Date | July 23, 2019 | ||||||
Actual Study Start Date ICMJE | March 11, 2019 | ||||||
Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome | ||||||
Official Title ICMJE | Open-Label Non-Comparative Study of the Effects of a Combination Antihypertensive Treatment With Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome | ||||||
Brief 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 antihypertensive therapy. Open-label non-comparative prospective study for 24 week for each patient. |
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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):
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:
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: perindopril + moxonidine
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). |
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Study Arms ICMJE | Experimental: perindopril + moxonidine
perindopril 10 mg + moxonidine 0.4 or 0.6 mg a day (given as two divided doses).
Intervention: Drug: perindopril + moxonidine
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
120 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 30, 2020 | ||||||
Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Russian Federation | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04023565 | ||||||
Other Study ID Numbers ICMJE | MOXOD001 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Sergey V. Nedogoda, Volgograd State Medical University | ||||||
Study Sponsor ICMJE | Sergey V. Nedogoda | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Volgograd State Medical University | ||||||
Verification Date | July 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |