Arterial HypertensionAcADEMENCT03539627
Azilsartan Medoxomil in Hypertensive pAtients With Stable Ischemic Heart Disease and DiabEtes MEllitus.
An observational study of Arterial Hypertension and Diabetes Mellitus, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Hypertension, Diabetes Mellitus, Stable Chronic Angina
- What is being tested?
- Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]
- Type of treatment
- Pill or oral medicine
- How many people
- 184 participants
- Where
- 1 siteRussia
- Study dates
- 7 Nov 2018to 29 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with arterial hypertension associated with stable ischemic heart disease and type 2 diabetes mellitus
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed description
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.
During the study 5 visits to the research center are planned. At each visit, a physical examination, sampling of bio-samples for evaluation in the local laboratory, and collection of information on adverse events will be performed. 24-hours monitoring of blood pressure will be performed at screening, after 1 months of therapy and at the final visit (6 months of therapy).
Data will be collected during 5 consecutive visits to the research center. The observation period will be about 6 months, the active treatment period will be at least 6 months (24 weeks). Patients included in the study will be observed in an outpatient clinic according to the local practice of the research center.
It is planned that potentially eligible patients will be invited to the screening visit. Based on the results of daily monitoring of blood pressure, a final decision will be made about the suitability of the patient to participate in the study. Patients who have not reached the target values of blood pressure will start taking the study drug (Edarbi). By not achieving the target values of blood pressure, the mean daily systolic blood pressure is more than 130 mm Hg and the diastolic blood pressure is more than 90 mm Hg. The length of time between Visit 1 and Visit 2 is suspected to be no longer than 2 weeks.
All examinations (examination and evaluation of vital functions, laboratory tests, instrumental examinations) will be performed in accordance with the general standards of medical practice and in accordance with the routine practice of the institution.
Based on the number of patients hospitalized in the Research Institute For Complex Issues Of Cardiovascular Diseases (1500 patients), as well as the data on the prevalence of type 2 diabetes in this group (23.5%, 353 patients), the required sample size will be 184 patients (Confidence interval ± 5 %, the confidence probability is 95%).
SS = Z2 * (p) * (1-p) C2 where: Z = Z factor (1,96 for 95% confidence interval) p = percentage of respondents required, in decimal form (0,5 by default) c = confidence interval, in decimal form (for example, 0,04 = ±4%).
- Being tested
- Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]
- Keywords
- diabetes mellitus, Edarbi, hypertension
- Medical subject headings
- Hypertension, Diabetes Mellitus, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]Drug
patients are to receive azilsartan medoxomil
| Study group | Role | What they receive |
|---|---|---|
| patients with hypertension, CAD and diabetes | Patients with hypertension associated with stable CAD and diabetes on azilsartan medoxomil (Edarbi) therapy Receives: Drug: Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Dynamics of clinical SBP from the baseline against the background of therapy with Edarbi®
Measured: interval: up to 24 weeks
Secondary outcomes (5)
Diastolic blood pressure
Dynamics of clinical DBP from the baseline against the background of therapy with Edarbi® (interval: Visit of inclusion - Visit 5);
Measured: interval: up to 24 weeks
Dynamics of renal function (filtration)
Dynamics of eGFR
Measured: interval: up to 24 weeks
Edarbi® efficacy
proportion of patients who respond to Edarbi® therapy (defined as decrease of SBP≥ 20 mm Hg or decrease of DBP≥10 mm Hg)
Measured: interval: up to 24 weeks
Dynamics of renal function (evidence of kidney injury)
N-GAL-dynamics
Measured: interval: up to 24 weeks
Dynamics of renal function (proteinuria detecton)
UACR dynamics
Measured: interval: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start7 Nov 2018
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Barbarash, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539627
- Sponsor's protocol ID
- IISR-2017-102380
- Acronym
- AcADEME
- Status last verified
- Oct 2022
- First submitted
- 2 May 2018
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03539627
- Acronym / sponsor ID
- AcADEME / IISR-2017-102380
- Keywords
- diabetes mellitus, Edarbi, hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, RussiaUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
During the study 5 visits to the research center are planned. At each visit, a physical examination, sampling of bio-samples for evaluation in the local laboratory, and collection of information on adverse events will be performed. 24-hours monitoring of blood pressure will be performed at screening, after 1 months of therapy and at the final visit (6 months of therapy).
Data will be collected during 5 consecutive visits to the research center. The observation period will be about 6 months, the active treatment period will be at least 6 months (24 weeks). Patients included in the study will be observed in an outpatient clinic according to the local practice of the research center.
It is planned that potentially eligible patients will be invited to the screening visit. Based on the results of daily monitoring of blood pressure, a final decision will be made about the suitability of the patient to participate in the study. Patients who have not reached the target values of blood pressure will start taking the study drug (Edarbi). By not achieving the target values of blood pressure, the mean daily systolic blood pressure is more than 130 mm Hg and the diastolic blood pressure is more than 90 mm Hg. The length of time between Visit 1 and Visit 2 is suspected to be no longer than 2 weeks.
All examinations (examination and evaluation of vital functions, laboratory tests, instrumental examinations) will be performed in accordance with the general standards of medical practice and in accordance with the routine practice of the institution.
Based on the number of patients hospitalized in the Research Institute For Complex Issues Of Cardiovascular Diseases (1500 patients), as well as the data on the prevalence of type 2 diabetes in this group (23.5%, 353 patients), the required sample size will be 184 patients (Confidence interval ± 5 %, the confidence probability is 95%).
SS = Z2 * (p) * (1-p) C2 where: Z = Z factor (1,96 for 95% confidence interval) p = percentage of respondents required, in decimal form (0,5 by default) c = confidence interval, in decimal form (for example, 0,04 = ±4%).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with hypertension, CAD and diabetes | – | Drug: Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]Patients with hypertension associated with stable CAD and diabetes on azilsartan medoxomil (Edarbi) therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with arterial hypertension associated with stable ischemic heart disease and type 2 diabetes mellitus
Key inclusion criteria (6 listed)
- 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.
- Investigator's decision on the advisability of correction of previously prescribed therapy with the replacement of ACE inhibitors or other ARBs with azilsartan medoxomil.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]patients are to receive azilsartan medoxomil | Drug | patients with hypertension, CAD and diabetes |
Primary outcome
Systolic blood pressure
Time frame: interval: up to 24 weeks
Dynamics of clinical SBP from the baseline against the background of therapy with Edarbi®
5 secondary outcomes
Diastolic blood pressure
Time frame: interval: up to 24 weeks
Dynamics of renal function (filtration)
Time frame: interval: up to 24 weeks
Edarbi® efficacy
Time frame: interval: up to 24 weeks
Dynamics of renal function (evidence of kidney injury)
Time frame: interval: up to 24 weeks
Dynamics of renal function (proteinuria detecton)
Time frame: interval: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Kochergina A.M., Barbarash O.L. Azilsartan medoxomil: opportunities and prospects in diabetes mellitus. "Arterial'naya Gipertenziya" ("Arterial Hypertension"). 2021;27(2):247-254. (In Russ.)Link provided by the sponsor.
Related trials for Arterial Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension and Diabetes Mellitus, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: interval: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.