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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05899920
Acronym
SAGA
Enrollment
190
Registered
2023-06-12
Start date
2022-03-11
Completion date
2024-12-31
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resistant Arterial Hypertension

Keywords

antihypertensive drugs, concentration, HPLC MS/MS

Brief summary

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.

Interventions

DIAGNOSTIC_TESTBlood samples will be taken for pharmacokinetics and pharmacogenetics

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

Sponsors

Ryazan State Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Plasma Concentration of lisinopril, valsartan, amlodipin, indapamide, metoprololday 1Number of Participants with antihypertensive drug concentraion below the limit of quantitative determination

Countries

Russia

Contacts

Primary ContactSergey V Seleznev, MD, PhD
sv.seleznev@gmail.com+79105749526
Backup ContactAlexey V Shchulkin, MD, PhD
alekseyshulkin@rambler.ru+79209520024

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026