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OpenTrials
Completed

NCT Number: NCT01122251

Efficacy and Safety of Lercanidipine and Valsartan in Patients With Essential Hypertension

The purpose of this study is to evaluate the safety and efficacy of fixed combination of lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged between 20 and 75
  • Essential hypertension at screening (-3 week)

Randomization Criteria:

  • Essential hypertension at baseline (90mmHg≤sitDBP≤109mmHg, except sitSBP≥180)

Exclusion criteria

  • Mean sitDBP≥110mmHg or sitSBP≥180
  • Secondary hypertension or suspected secondary hypertension
  • Uncontrolled diabetes
  • Severe heart disease or severe cerebrovascular disease
  • clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
  • History of malignant disease
  • Autoimmune disease
  • Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial

Treatment and study plan

Lercanidipine + Valsartan

Drug

L10/V80, L20/V80, L10/V160, L20/V160

Lercanidipine or Valsartan

Drug

L10, L20, V80, V160

Placebo

Drug

Placebo of Lercanidipine and Valsartan

Primary outcomes

  1. sitDBP

    Time frame: Baseline, Week 8

    Average changes from baseline in sitDBP

Secondary outcomes

  1. sitDBP

    Time frame: Week 4, 8

    Response rates (proportion of patients sitDBP<90mmHg or ≥10-mmHg reduction from baseline)

  2. sitDBP

    Time frame: Week 4

    Average changes from baselin in sitDBP

  3. sitSBP

    Time frame: Week 4, 8

    Average changes from baselini in sitSBP

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

A Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy Phase II Trial to Evaluate the Efficacy and Safety of the Combinations of Lercanidipine and Valsartan in Comparison to Each Component Administered Alone and to Determine the Optimal Dose Combinations in Patients With Essential Hypertension

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 13, 2010
Registry last updated
Feb 18, 2011

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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