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OpenTrials
Completed

NCT Number: NCT03038451

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Istanbul University Istanbul Medical Faculty Clinical Pharmacology Department

Istanbul, Fatih, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

  1. Evaluation of change in diastolic blood pressure up to 4th week of the treatment

    Time frame: 4 weeks

  2. Evaluation of change in diastolic blood pressure up to 8th week of the treatment

    Time frame: 8 weeks

  3. Evaluation of change in systolic blood pressure up to 8th week of the treatment

    Time frame: 8 weeks

  4. Evaluation of change in systolic blood pressure from 4th to 8th week of the treatment

    Time frame: 4 to 8 weeks

  5. Evaluation of change in diastolic blood pressure from 4th to 8th week of the treatment

    Time frame: 4 to 8 weeks

  6. Evaluation of treatment response rates from 4th to 8th week of the treatment

    Time frame: 4 to 8 weeks

Sponsors and collaborators

Lead sponsor

Neutec Ar-Ge San ve Tic A.Ş

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 31, 2017
Registry last updated
Jun 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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