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Azilsartan Medoxomil in Hypertensive pAtients With Stable Ischemic Heart Disease and DiabEtes MEllitus. (AcADEME)

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ClinicalTrials.gov Identifier: NCT03539627
Recruitment Status : Not yet recruiting
First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Olga Barbarash, Research Institute for Complex Problems of Cardiovascular Diseases, Russia

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.

Condition or disease Intervention/treatment
Arterial Hypertension Diabetes Mellitus Stable Chronic Angina Drug: Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]

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%).


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Study Type : Observational
Estimated Enrollment : 184 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021


Group/Cohort Intervention/treatment
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]
patients are to receive azilsartan medoxomil




Primary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: interval: up to 24 weeks ]
    Dynamics of clinical SBP from the baseline against the background of therapy with Edarbi®


Secondary Outcome Measures :
  1. Diastolic blood pressure [ Time Frame: interval: up to 24 weeks ]
    Dynamics of clinical DBP from the baseline against the background of therapy with Edarbi® (interval: Visit of inclusion - Visit 5);

  2. Dynamics of renal function (filtration) [ Time Frame: interval: up to 24 weeks ]
    Dynamics of eGFR

  3. Edarbi® efficacy [ Time Frame: interval: up to 24 weeks ]
    proportion of patients who respond to Edarbi® therapy (defined as decrease of SBP≥ 20 mm Hg or decrease of DBP≥10 mm Hg)

  4. Dynamics of renal function (evidence of kidney injury) [ Time Frame: interval: up to 24 weeks ]
    N-GAL-dynamics

  5. Dynamics of renal function (proteinuria detecton) [ Time Frame: interval: up to 24 weeks ]
    UACR dynamics


Biospecimen Retention:   Samples Without DNA
Serum, urine


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   adult patients only
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with arterial hypertension associated with stable ischemic heart disease and type 2 diabetes mellitus
Criteria

Inclusion Criteria:

  1. Informed consent signed by the patient.
  2. Men and women aged 18 years and older with a previously diagnosed hypertension and type 2 diabetes mellitus and stable ischemic heart disease.
  3. Stable therapy of hypertension, T2DM and ischemic heart disease for at least 12 weeks before screening.
  4. 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.

  5. Investigator's decision on the advisability of correction of previously prescribed therapy with the replacement of ACE inhibitors or other ARBs with azilsartan medoxomil.

Exclusion Criteria:

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

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Responsible Party: Olga Barbarash, Professor, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
ClinicalTrials.gov Identifier: NCT03539627     History of Changes
Other Study ID Numbers: IISR-2017-102380
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Olga Barbarash, Research Institute for Complex Problems of Cardiovascular Diseases, Russia:
diabetes mellitus
Edarbi
hypertension

Additional relevant MeSH terms:
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Diabetes Mellitus
Hypertension
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Angina, Stable
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Azilsartan medoxomil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action