NCT03038451

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2013

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2017

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

3.9 years

First QC Date

January 14, 2017

Last Update Submit

June 13, 2018

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Evaluation of change in systolic blood pressure up to 4th week of the treatment

    4 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

s-amlodipine besylate 2,5 and 5 mg tablets

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

Interventions

S-NOR (s-amlodipine) 2,5 mg & 5 mg tabletDRUG
s-amlodipine besylate 2,5 and 5 mg tablets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Istanbul Medical Faculty Clinical Pharmacology Department

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 29649885RESULT

MeSH Terms

Conditions

Hypertension

Interventions

levamlodipineTablets

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2017

First Posted

January 31, 2017

Study Start

March 20, 2013

Primary Completion

February 14, 2017

Study Completion

February 14, 2017

Last Updated

June 15, 2018

Record last verified: 2018-06

Locations

TU(1)