NCT03539627

Brief Summary

One-center, observational, non-interventional, prospective study of the efficacy of azilsartan medoxomil in patients with arterial hypertension associated with stable ischemic heart disease and type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

November 7, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

3.5 years

First QC Date

May 2, 2018

Last Update Submit

October 24, 2022

Conditions

Arterial HypertensionDiabetes MellitusStable Chronic Angina

Keywords

diabetes mellitusEdarbihypertension

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure

    Dynamics of clinical SBP from the baseline against the background of therapy with Edarbi®

    interval: up to 24 weeks

Secondary Outcomes (5)

  • Diastolic blood pressure

    interval: up to 24 weeks

  • Dynamics of renal function (filtration)

    interval: up to 24 weeks

  • Edarbi® efficacy

    interval: up to 24 weeks

  • Dynamics of renal function (evidence of kidney injury)

    interval: up to 24 weeks

  • Dynamics of renal function (proteinuria detecton)

    interval: up to 24 weeks

Study Arms (1)

patients with hypertension, CAD and diabetes

Patients with hypertension associated with stable CAD and diabetes on azilsartan medoxomil (Edarbi) therapy

Drug: Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]

Interventions

Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]DRUG

patients are to receive azilsartan medoxomil

patients with hypertension, CAD and diabetes

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsadult patients only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with arterial hypertension associated with stable ischemic heart disease and type 2 diabetes mellitus

You may qualify if:

  • Informed consent signed by the patient.
  • Men and women aged 18 years and older with a previously diagnosed hypertension and type 2 diabetes mellitus and stable ischemic heart disease.
  • Stable therapy of hypertension, T2DM and ischemic heart disease for at least 12 weeks before screening.
  • Not achievement of target values \* of blood pressure against the background of previously prescribed and steadily accepted antihypertensive therapy.
  • \* not reaching the target figures of arterial pressure means mean systolic blood pressure more than 130 mm Hg and / or an average diastolic blood pressure more than 90 mmHg.
  • Investigator's decision on the advisability of correction of previously prescribed therapy with the replacement of ACE inhibitors or other ARBs with azilsartan medoxomil.

You may not qualify if:

  • Contraindications to the azilsartan medoxomil in accordance with instruction for use, including information on the individual intolerance of the drug.
  • Any circumstances in the opinion of the investigator that interfere with the participation of the patient in the study.
  • The patient included in the study is an employee of the center or a relative of the investigator.
  • Participation in other clinical trials. Participation in register studies is allowed.
  • Any disease or condition that leads to a decrease in the patient's life expectancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anastasia Kochergina

Kemerovo, 650002, Russia

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, urine

MeSH Terms

Conditions

HypertensionDiabetes MellitusAngina, Stable

Interventions

azilsartan medoxomilTabletsazilsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAngina PectorisMyocardial IschemiaHeart DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

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

May 2, 2018

First Posted

May 29, 2018

Study Start

November 7, 2018

Primary Completion

April 29, 2022

Study Completion

April 29, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations

RU(1)