NCT03006796

Observational Study of Azilsartan/Chlorthalidone and Irbesartan/Hydrochlorothiazide in Hypertension and Obesity.

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).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 94 (actual)
• Sponsor: Russian Heart Failure Society · Academic / Other
• Sex: All
• Age: 35 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Arterial Hypertension

Timeline

• Start date: 2017-01-16
• Primary completion: 2020-02-01
• Completion: 2020-03-31
• First posted: 2016-12-30
• Last updated: 2020-10-19

Locations

1 site across 1 country: Russia