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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03006796
Other study ID # IISR-2015-101477
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 16, 2017
Est. completion date March 31, 2020

Study information

Verified date October 2020
Source Russian Heart Failure Society
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational prospective study of azilsartan medoxomil / chlorthalidone compared with irbesartan / hydrochlorothiazide in routine therapy of patients with arterial hypertension and obesity.


Description:

Observational Prospective stUdy of aZilsartan medoxomil/ chlorthalidone compared with irbesartan/hydrochlorothiaZide combination therapy in patients with arteriaL hypertension and obEsity in routine clinical practice (PUZZLE). The study population is 94 patients with untreated or poorly controlled arterial hypertension and obesity. The main inclusion criteria are: 1. Male and female 35-55 year old. 2. Diagnosis of essential arterial hypertension I-II grade. 3. Patients with obesity (BMI ≥ 30 kg/m²) 4. Patients with untreated arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg and no previous antihypertensive treatment. 5. Patients with poorly controlled arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive treatment. 6. Written informed consent. The main exclusion criteria are: 1. Patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease ≥ 4 grade, diabetes). 2. Patients with secondary arterial hypertension. 3. Patients with intolerance of angiotensin II receptor blockers, thiazide diuretic. 4. Patients with contraindication to study drugs in accordance with Russian instruction. 5. Patients currently enrolled in other clinical trials. The treatment period is 6 months. The study plan includes 4 basic and 1 additional visits are planned: initial visit, 3 follow-ups (including additional) and study-end visit.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date March 31, 2020
Est. primary completion date February 2020
Accepts healthy volunteers No
Gender All
Age group 35 Years to 55 Years
Eligibility Inclusion Criteria: 1. male and female 35-55 year old, 2. diagnosis of I-II grade essential AH, 3. patients with obesity (BMI = 30 kg/m²), 4. patients with untreated AH (office SBP = 140 mmHg, DBP = 90 mmHg, no previous antihypertensive therapy), 5. patients with poorly controlled AH (office SBP = 140 mmHg, DBP = 90 mmHg on previous antihypertensive therapy), 6. written informed consent form (ICF). Exclusion Criteria: 1. patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease stage = 4, diabetes), 2. patients with intolerance of ARB, thiazide diuretics, 3. secondary AH, 4. patients with contraindication to study drugs in accordance with Russian instruction, 5. patients currently enrolled in other clinical trials.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Russian Federation City Hospital ?5 Moscow

Sponsors (1)

Lead Sponsor Collaborator
Russian Heart Failure Society

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinic systolic blood pressure lowering. Lowering of clinic systolic blood pressure. From baseline (Month 0) to the study-end visit (Month 6)
Secondary 24-hour systolic brachial and central blood pressure lowering. Lowering of ambulatory brachial and central blood pressure. From baseline (Month 0) to the study-end visit (Month 6).
Secondary 24-hour aortic pulse wave velocity reduction. Lowering of ambulatory aortic pulse wave velocity. From baseline (Month 0) to the study-end visit (Month 6).
Secondary change in proportion of patients with normal and abnormal LV geometry with assessment of LV mass index and relative wall thickness. Normalization of abnormal left ventricle geometry assessed by left ventricle mass index and relative wall thickness. From baseline (Month 0) to the study-end visit (Month 6).
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