Efficacy and Safety of S-amlodipine 2,5 mg and 5 mg in Hypertension Patients

Efficacy and Safety of S-amlodipine 2,5 mg and 5 mg in Hypertension Patients: Open-label, Local, Phase IV Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03038451

Enrollment

Registered

2017-01-31

Start date

2013-03-20

Completion date

2017-02-14

Last updated

2018-06-15

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

Conditions

Hypertension

Brief summary

s-amlodipine besylate 2,5 mg tablet will be administered to patients have not received any hypertension treatment before or have received any of anti-hypertensive mono-therapy for the first four weeks of treatment. By increasing dose, s-amlodipine besylate 5 mg tablet will be administered for the last four weeks (4-8 weeks).

Interventions

DRUGS-NOR (s-amlodipine) 2,5 mg & 5 mg tablet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female outpatients 18 years and older. * Hypertension patients have not received any anti-hypertensive treatment before ( ≥ 140 mmHg MSSBP \< 160 mmHg, ≥ 90 mmHg MSDBP \< 100mmHg). * Hypertension patients controlled with single medicine. * Patients giving written informed consent without being under any influence.

Exclusion criteria

* Pregnant patients, nursing mothers or female patients who have potential for childbearing and do not use any effective contraceptive method. * Allergy or hypersensitivity to dihydropyridines. * Patients receive more than one anti-hypertensive medicine. * Patients with seconder hypertension. * Patients with severe hypertension, myocardial infarction, NYHA stage 2-4 cardiac insufficiency, history of cerebrovascular disease, past ischemic attack, encephalopathy, underwent coronary artery bypass surgery or percutaneous coronary intervention, second or third degree heart block or symptomatic arrhythmia without pacemaker, clinically significant heart valve disease, potential life-threatening or symptomatic arrhythmia, simultaneous unstable angina pectoris, type I diabetes mellitus, atrial fibrillation until the last 12 months. * Uncontrolled type II diabetes mellitus. * Patients with significant liver disease (ALT, AST must be \> 2XULN in beginning, patients with esophageal varices, portacaval shunt). * Patients with significant kidney disease (GFR \<60 ml/min according to Cockcroft-Gault formula). * Patients with volume depletion. * Patients with pancreas disease. * Patients with gastrointestinal disease which may effect absorption. * Drug/narcotic and alcohol abuse until the last 12 months. * Patients with central nervous system disease and taking medicine for this reason. * History of incompatibility with medical regimes or patients do not want to adhere the study protocol. * Persons directly involved in the management of this protocol.

Design outcomes

Primary

Measure	Time frame
Evaluation of change in systolic blood pressure up to 4th week of the treatment	4 weeks

Secondary

Measure	Time frame
Evaluation of change in diastolic blood pressure up to 8th week of the treatment	8 weeks
Evaluation of change in systolic blood pressure up to 8th week of the treatment	8 weeks
Evaluation of change in diastolic blood pressure up to 4th week of the treatment	4 weeks
Evaluation of change in diastolic blood pressure from 4th to 8th week of the treatment	4 to 8 weeks
Evaluation of treatment response rates from 4th to 8th week of the treatment	4 to 8 weeks
Evaluation of change in systolic blood pressure from 4th to 8th week of the treatment	4 to 8 weeks

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026