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OpenTrials
Completed

NCT Number: NCT02145104

Efficacy/Safety of Cilnidipine Plus Valsartan Versus Valsartan in Patients With Hypertension

The purpose of this study is to evaluate of efficacy and safety of cilinidipine plus valsartan and valsartan alone in patients with essential hypertension inadequately controlled on valsartan monotherapy

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Kyung-gi, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • essential hypertension patients whose blood pressure is not controlled before the study (sDBP≥90mmHg for drug-treated patients, sDBP≥95mmHg for drug-naive patients)

Exclusion criteria

  • sSBP≥80mmHg after 4weeks of valsartan 160mg treatment
  • has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers

Treatment and study plan

valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg

Drug

Primary outcomes

  1. change from baseline in mean sDBP

    Time frame: 8 weeks

Secondary outcomes

  1. change from baseline in mean sDBP

    Time frame: 4 weeks

  2. change from baseline in mean sSBP

    Time frame: 4, 8 weeks

Sponsors and collaborators

Lead sponsor

IlDong Pharmaceutical Co Ltd

Industry

Registry information

Official study title

Comparison of the Efficacy and Safety of Cilnidipine 10mg/Valsartan 160mg Combination Therapy, Cilnidipine 5mg/Valsartan 160mg Combination Therapy and Valsartan 160mg Monotherapy in Hypertensive Patients Inadequately Controlled With Valsartan 160mg Monotherapy: a Multicenter, Randomized, Double Blind Phase III Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 22, 2014
Registry last updated
Jun 13, 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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