NCT04023565

Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome

Open-Label Non-Comparative Study of the Effects of a Combination Antihypertensive Treatment With Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Sergey V. Nedogoda · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arterial Hypertension
• Metabolic Syndrome

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-03-11
• Primary completion: 2020-06-30
• Completion: 2020-12-30
• First posted: 2019-07-17
• Last updated: 2019-07-23

Locations

1 site across 1 country: Russia