Observational Study of Azilsartan/Chlorthalidone and Irbe... | NCT03006796

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

NCT03006796

Sponsor

Russian Heart Failure Society

Status

Completed

Last Update Posted

Oct 19, 2020Actual

Enrollment

94Actual

Phase

Not provided

Conditions

Arterial Hypertension

Interventions

Not provided

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2017Actual

Primary Completion Date

Feb 2020Actual

Completion Date

Mar 31, 2020Actual

First Submitted Date

Dec 27, 2016

First Submission Date that Met QC Criteria

Dec 27, 2016

First Posted Date

Dec 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2020

Last Update Posted Date

Oct 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:

Male and female 35-55 year old.
Diagnosis of essential arterial hypertension I-II grade.
Patients with obesity (BMI ≥ 30 kg/m²)
Patients with untreated arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg and no previous antihypertensive treatment.
Patients with poorly controlled arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive treatment.
Written informed consent.

The main exclusion criteria are:

Patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease ≥ 4 grade, diabetes).
Patients with secondary arterial hypertension.
Patients with intolerance of angiotensin II receptor blockers, thiazide diuretic.
Patients with contraindication to study drugs in accordance with Russian instruction.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

94Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinic systolic blood pressure lowering.	Lowering of clinic systolic blood pressure.	From baseline (Month 0) to the study-end visit (Month 6)

Secondary Outcomes

Measure	Description	Time Frame
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).
24-hour aortic pulse wave velocity reduction.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yury A Vasyuk, MD	Russian HFS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
City Hospital №5		Moscow		107015	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D009765	Obesity

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D050177	Overweight
D044343	Overnutrition

Browse Leaves

Not provided

Browse Branches

Not provided