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

NCT ID: NCT03038451

Last Updated: 2018-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-20
• Study Completion Date: 2017-02-14

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).

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

s-amlodipine besylate 2,5 and 5 mg tablets

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neutec Ar-Ge San ve Tic A.Ş

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istanbul University Istanbul Medical Faculty Clinical Pharmacology Department

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Sen S, Demir M, Yigit Z, Uresin AY. Efficacy and Safety of S-Amlodipine 2.5 and 5 mg/d in Hypertensive Patients Who Were Treatment-Naive or Previously Received Antihypertensive Monotherapy. J Cardiovasc Pharmacol Ther. 2018 Jul;23(4):318-328. doi: 10.1177/1074248418769054. Epub 2018 Apr 12.

Reference Type: RESULT

PMID: 29649885 (View on PubMed)

Other Identifiers

NEU-07.12

Identifier Type: -

Identifier Source: org_study_id