Efficacy and Safety of S-amlodipine 2,5 mg and 5 mg in Hy... | NCT03038451

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

NCT03038451

Sponsor

Neutec Ar-Ge San ve Tic A.Ş

Status

Completed

Last Update Posted

Jun 15, 2018Actual

Enrollment

43Actual

Phase

Phase 4

Conditions

Hypertension

Interventions

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

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2013Actual

Primary Completion Date

Feb 14, 2017Actual

Completion Date

Feb 14, 2017Actual

First Submitted Date

Jan 14, 2017

First Submission Date that Met QC Criteria

Jan 27, 2017

First Posted Date

Jan 31, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2018

Last Update Posted Date

Jun 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Label	Type	Description	Intervention Names
s-amlodipine besylate 2,5 and 5 mg tablets	Experimental		Drug: S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet

Name	Type	Description	Arm Group Labels	Other Names
S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet	Drug		s-amlodipine besylate 2,5 and 5 mg tablets

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

Measure	Description	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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul University Istanbul Medical Faculty Clinical Pharmacology Department		Istanbul	Fatih	34093	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29649885	Result	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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
C542574	levamlodipine
D013607	Tablets

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations