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OpenTrials
Completed

NCT Number: NCT01928628

Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients

This study aims to compare and assess the efficacy and the safety of the combination agent of Lercanidipine and Valsartan and monotherapy of Lercanidipine alone in patients with essential hypertension

Completed

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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 Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged ≥ 20 to ≤75 years old
  • Patient with essential hypertension

Exclusion criteria

  • When the BP level measured at screening was sitDBP>120 mmHg or sitSBP >180 mmHg
  • Patient with difference in repeatedly measured blood pressures from the selected arm at screening was sitSBP≥ 20mmHg or sitDBP ≥ 10mmHg

Treatment and study plan

Lercanidipine 10mg

Drug

Lercanidipine10mg /Valsartan 80mg

Drug

Lercanidipine 10mg /Valsartan 160mg

Drug

Lercanidipin 10mg Placebo

Drug

Lercanidipine10mg /Valsartan 80mg Placebo

Drug

Lercanidipine 10mg /Valsartan 160mg Placebo

Drug

Primary outcomes

  1. Change in mean sitDBP from week 0 to week 40

    Time frame: 40 weeks

Secondary outcomes

  1. Response rate at week 4 and 8

    Time frame: 4 weeks and 8 weeks

    Proportion (%) of patients with mean sitDBP<90mmHg or proportion (%) of patients with mean reduction of sitDBP ≥10mmHg from week 0

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

A Randomized, Multicenter, Parallel Design Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients Who Are Not Adequately Controlled on Lercanidipine 10mg Monotherapy.

Important dates

Study start
2012
Primary completion
2013
First posted
Aug 27, 2013
Registry last updated
Aug 28, 2013

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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