Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-11

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was planned to assess the concentration of antihypertensive drugs in the blood plasma in patients with controlled and uncontrolled arterial hypertension. Methods: it is planned to include patients with arterial hypertension taking 3 antihypertensive drugs (indapanide, lisinopril or valsartan, amlodipine). Based on the results of 24-hour blood pressure monitoring, the patients will be randomized into two groups: The first group - the patients with controlled AH; The second group - the patients with uncontrolled AH. Venous blood was taken in both groups of the patients in the morning before and 2 hours after taking drugs to assess the concentration of lisinopril, amlodipine, valsartan and indapamide. Concentation of assesed antihypertensive drugs will be compared in both groups.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

NCT00523744

Hypertension

COMPLETED PHASE3

Comparison of Amlodipine and Aliskiren in Diabetic Hypertensive Patient With Blood Pressure Not Controlled by Losartan

NCT01409408

Hypertension Diabetes Mellitus

WITHDRAWN PHASE4

Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy

NCT00351130

Hypertension

COMPLETED PHASE4

Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension

NCT00413049

Hypertension

COMPLETED PHASE3

Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension

NCT00353912

Hypertension

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Resistant Arterial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Controlled arterial hypertension

Controlled arterial hypertension according the results of 24-hour blood pressure monitoring.

Blood samples will be taken for pharmacokinetics and pharmacogenetics

Group Type ACTIVE_COMPARATOR

Blood samples will be taken for pharmacokinetics and pharmacogenetics

Intervention Type DIAGNOSTIC_TEST

To assess antihypertensive drugs concentration (lisinopril, valsartan, amlodipine, indapamide

Uncontrolled arterial hypertension

Uncontrolled arterial hypertension according the results of 24-hour blood pressure monitoring.

Blood samples will be taken for pharmacokinetics and pharmacogenetics

Group Type EXPERIMENTAL

Blood samples will be taken for pharmacokinetics and pharmacogenetics

Intervention Type DIAGNOSTIC_TEST

To assess antihypertensive drugs concentration (lisinopril, valsartan, amlodipine, indapamide

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood samples will be taken for pharmacokinetics and pharmacogenetics

To assess antihypertensive drugs concentration (lisinopril, valsartan, amlodipine, indapamide

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Signed informed consent form;
* An established diagnosis of AH based on the Clinical Guidelines "Arterial hyperten-sion in adults", approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020;
* Mandatory patient compliance with recommendations for lifestyle modification in accordance with the Clinical Guidelines "Arterial hypertension in adults", approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020 .
* Regular administration of any two antihypertensive drugs (lisinopril, amlodipine, valsartan) in combination with indapamide for a month, possibly in fixed combinations, in stable dosages;
* Fertile female patients must use proper methods of contraception throughout the study period.