Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome

Status Recruiting

Clinical 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 antihypertensive therapy.

Open-label non-comparative prospective study for 24 week for each patient.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04023565
Study type	Interventional
Source	Volgograd State Medical University
Contact	Sergey V. Nedogoda, Professor
Phone	+79023643226
Email	nedogodasv@rambler.ru
Status	Recruiting
Phase	Phase 4
Start date	March 11, 2019
Completion date	December 30, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people 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.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Moxonidine + Perindopril in Hypertensive Patients With Metabolic Syndrome — COMPOSER

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms