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

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).

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Istanbul University Istanbul Medical Faculty Clinical Pharmacology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: s-amlodipine besylate 2,5 and 5 mg tablets	Drug: S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Neutec Ar-Ge San ve Tic A.Ş

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2013
• Primary Completion (Actual): February 14, 2017
• Study Completion (Actual): February 14, 2017

Study Registration Dates

• First Submitted: January 14, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): June 15, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine
• Other Study ID Numbers: NEU-07.12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided