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

NCT03006796 | Completed DMC

• 1 other identifier: IISR-2015-101477
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arterial Hypertension

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• Clinic systolic blood pressure lowering.

  Lowering of clinic systolic blood pressure.

  From baseline (Month 0) to the study-end visit (Month 6)

Secondary Outcomes (3)

• 24-hour systolic brachial and central blood pressure lowering.

  From baseline (Month 0) to the study-end visit (Month 6).

• 24-hour aortic pulse wave velocity reduction.

  From baseline (Month 0) to the study-end visit (Month 6).

• change in proportion of patients with normal and abnormal LV geometry with assessment of LV mass index and relative wall thickness.

  From baseline (Month 0) to the study-end visit (Month 6).

Study Arms (2)

group 1 (AZL/C)

Group 1 - patients receiving azilsartan medoxomil/chlorthalidone 40/12.5 mg or 40/25 mg per os once a day for 6 months.

group 2 (IRB/H)

Group 2 - patients receiving irbesartan/hydrochlorothiazide 150/12.5 mg or 300/25 mg per once a day for 6 months.

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population is 94 patients with untreated or poorly controlled arterial hypertension and obesity 35-55 years old.

You may qualify if:

• male and female 35-55 year old,
• diagnosis of I-II grade essential AH,
• patients with obesity (BMI ≥ 30 kg/m²),
• patients with untreated AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg, no previous antihypertensive therapy),
• patients with poorly controlled AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive therapy),
• written informed consent form (ICF).

You may not qualify if:

• patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease stage ≥ 4, diabetes),
• patients with intolerance of ARB, thiazide diuretics,
• secondary AH,
• patients with contraindication to study drugs in accordance with Russian instruction,
• patients currently enrolled in other clinical trials.

Sponsors & Collaborators

• Russian Heart Failure Society: lead

Study Sites (1)

City Hospital №5

Moscow, 107015, Russia

Location

MeSH Terms

Conditions

Hypertension; Obesity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yury A Vasyuk, MD

  Russian HFS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: December 30, 2016
• Study Start: January 16, 2017
• Primary Completion: February 1, 2020
• Study Completion: March 31, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)