Open-Label Non-Comparative Study of the Effects of a Combination Antihypertensive Treatment With Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome
Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome
Sponsors
Source
Volgograd State Medical University
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Is Us Export
No
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.
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):
1. ACEi (except perindopril) + diuretic (HCTZ or indapamide)
2. ACEi (except perindopril) + amlodipine
3. ARB+ diuretic (HCTZ or indapamide)
4. 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:
1. Withdrawal of informed consent by the patient at any time of the study.
2. Need for uncontrolled hypertension management occurring more than 2 times weekly
throughout the 2 consecutive weeks during study period.
3. Need for the third antihypertensive drug.
Overall Status
Recruiting
Start Date
2019-03-11
Completion Date
2020-12-30
Primary Completion Date
2020-06-30
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change in Pulse wave velocity (PWV) |
baseline and 24 weeks |
|
Change in Central Blood Pressure (BP) |
baseline and 24 weeks |
|
Change in Reflected wave index |
baseline and 24 weeks |
Secondary Outcome
Measure |
Time Frame |
|
Change in carbohydrate and lipid metabolism parameters markers |
baseline and 24 weeks |
|
Change in the adipokine level |
baseline and 24 weeks |
|
Change in the Inflammatory marker level |
baseline and 24 weeks |
|
Change in the renin-angiotensin-aldosterone system hyperactivation marker level |
baseline and 24 weeks |
|
Change in the sympathoadrenal system hyperactivation marker levels |
baseline and 24 weeks |
|
Proportion of patients achieved target BP level |
Week 4, Week 12, Week 24 |
Enrollment
120
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
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).
Arm Group Label
perindopril + moxonidine
Eligibility
Criteria
Inclusion Criteria:
1. Patients (male and female) aging 18 to 70 years.
2. Grade 1, 2 AH (SBP 140-179 mm Hg and/or DBP 90-109 mm Hg according 2018 ESH/ESC
guidelines)
3. PWV > 10 m/s
4. 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
5. Metabolic syndrome diagnosed by the 2009 Russian Society of Cardiology (RSC) National
Guidelines criteria
1. THE MAIN SIGN: central (abdominal) obesity defined as waist circumference (WC)
above 80 cm in women and above 94 cm in men.
2. ADDITIONAL 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.
6. Body Mass Index (BMI) >30 kg/m2.
7. For female patients with childbearing potential: negative pregnancy test and
willingness to use reliable methods of contraception until the study treatment
completion
8. Voluntarily signed informed consent to participate in the study.
Exclusion Criteria:
1. Contraindications for using ACEi and imidazoline receptor agonists.
2. Administration of perindopril or moxonidine during 6 months before the study onset.
3. 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).
4. 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).
5. Current diagnosis of unstable angina, acute and subacute myocardial infarction.
6. Heart failure of any functional class.
7. Grade 3 AH (≥ 180/110 mm Hg).
8. Sinus bradycardia (heart rate ≤50/min).
9. Type 1 or 2 diabetes mellitus.
10. Severe comorbidities, including mental diseases.
11. Acute conditions (infections, exacerbation of chronic diseases, injuries, surgical
interventions).
12. Alcohol abuse.
13. Pregnancy and lactation.
14. Serious renal dysfunction (Estimated Glomerular Filtration Rate (eGFR) by Chronic
Kidney Disease Epidemiology Collaboration (CKD-EPI) ≤30 ml/min/1.73 m2).
15. Serious hepatic dysfunction
16. Malignancies diagnosed and treated during the previous 5 years prior to study
enrollment.
17. Inability to understand the study and to give informed consent for participation in
it.
Gender
All
Minimum Age
18 Years
Maximum Age
70 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Sergey V. Nedogoda, Professor |
Principal Investigator |
Volgograd State Medical University |
Overall Contact
Location
Facility |
Status |
Contact |
|
Dept. of Therapy and Endocrinology Volgograd 400131 Russian Federation |
Recruiting |
Location Countries
Country
Russian Federation
Verification Date
2019-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor-Investigator
Investigator Affiliation
Volgograd State Medical University
Investigator Full Name
Sergey V. Nedogoda
Investigator Title
Dr.Med.Sc., Professor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Intervention Browse
Mesh Term
Perindopril
Moxonidine
Arm Group
Arm Group Label
perindopril + moxonidine
Arm Group Type
Experimental
Description
perindopril 10 mg + moxonidine 0.4 or 0.6 mg a day (given as two divided doses).
Firstreceived Results Date
N/A
Acronym
COMPOSER
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
July 15, 2019
Study First Submitted Qc
July 15, 2019
Study First Posted
July 17, 2019
Last Update Submitted
July 18, 2019
Last Update Submitted Qc
July 18, 2019
Last Update Posted
July 23, 2019
ClinicalTrials.gov processed this data on December 05, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.