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

February 17, 2011 updated by: LG Life Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

441

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Busan etc., Korea, Republic of
        • 23 sites in Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lercanidpine + Valsartan
L10/V80, L20/V80, L10/V160, L20/V160
Drug: Lercanidipine + Valsartan
L10/V80, L20/V80, L10/V160, L20/V160
Active Comparator: Lercanidipine or Valsartan
L10, L20, V80, V160
Drug: Lercanidipine or Valsartan
L10, L20, V80, V160
Placebo Comparator: Placebo
Placebo comparators of Lercanidipine and Valsartan
Drug: Placebo
Placebo of Lercanidipine and Valsartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sitDBP
Time Frame: Baseline, Week 8
Average changes from baseline in sitDBP
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sitDBP
Time Frame: Week 4, 8
Response rates (proportion of patients sitDBP<90mmHg or ≥10-mmHg reduction from baseline)
Week 4, 8
sitDBP
Time Frame: Week 4
Average changes from baselin in sitDBP
Week 4
sitSBP
Time Frame: Week 4, 8
Average changes from baselini in sitSBP
Week 4, 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 12, 2010

First Posted (Estimate)

May 13, 2010

Study Record Updates

Last Update Posted (Estimate)

February 18, 2011

Last Update Submitted That Met QC Criteria

February 17, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-ZVCL001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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