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

August 27, 2013 updated by: LG Life Sciences

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

449

Phase

  • Phase 3

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

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 ≥ 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

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lercanidipine 10mg
1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks)
Drug: Lercanidipine 10mg
Drug: Lercanidipine10mg /Valsartan 80mg Placebo
Drug: Lercanidipine 10mg /Valsartan 160mg Placebo
Experimental: Lercanidipine10mg /Valsartan 80mg
1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks)
Drug: Lercanidipine 10mg /Valsartan 160mg Placebo
Drug: Lercanidipine10mg /Valsartan 80mg
Drug: Lercanidipin 10mg Placebo
Experimental: Lercanidipine 10mg /Valsartan 160mg
1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks)
Drug: Lercanidipine10mg /Valsartan 80mg Placebo
Drug: Lercanidipin 10mg Placebo
Drug: Lercanidipine 10mg /Valsartan 160mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in mean sitDBP from week 0 to week 40
Time Frame: 40 weeks
40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks and 8 weeks

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.

General Publications

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

May 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

August 21, 2013

First Posted (Estimate)

August 27, 2013

Study Record Updates

Last Update Posted (Estimate)

August 28, 2013

Last Update Submitted That Met QC Criteria

August 27, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-ZVCL005

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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