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

April 22, 2024 updated by: Ryazan State Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Ryazan, Russian Federation, 390026
        • Recruiting
        • Ryzan State Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sergey S Yakushin, MD, PhD
        • Sub-Investigator:
          • Pavel Yu Mylnikov, MD, PhD
        • Sub-Investigator:
          • Elena N Yakusheva, MD, PhD
        • Sub-Investigator:
          • Natalia N Nikulina, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Exclusion Criteria:

  • Patient's connection with the organization or conducting of the study;
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Controlled arterial hypertension

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

Blood samples will be taken for pharmacokinetics and pharmacogenetics
Diagnostic test: Blood samples will be taken for pharmacokinetics and pharmacogenetics
To assess antihypertensive drugs concentration (lisinopril, valsartan, amlodipine, indapamide
Experimental: Uncontrolled arterial hypertension

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

Blood samples will be taken for pharmacokinetics and pharmacogenetics
Diagnostic test: Blood samples will be taken for pharmacokinetics and pharmacogenetics
To assess antihypertensive drugs concentration (lisinopril, valsartan, amlodipine, indapamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Concentration of lisinopril, valsartan, amlodipin, indapamide, metoprolol
Time Frame: day 1
Number of Participants with antihypertensive drug concentraion below the limit of quantitative determination
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryazan State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2022

Primary Completion (Estimated)

November 11, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAGA-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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