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

Primary Purpose

Essential Hypertension

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Lercanidipine + Valsartan

Lercanidipine or Valsartan

Placebo

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring hypertension, lercanidipine, valsartan

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

23 sites in Korea
Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Lercanidpine + Valsartan

Lercanidipine or Valsartan

Placebo

Arm Description

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

L10, L20, V80, V160

Placebo comparators of Lercanidipine and Valsartan

Outcomes

Primary Outcome Measures

sitDBP

Average changes from baseline in sitDBP

Secondary Outcome Measures

sitDBP

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

sitDBP

Average changes from baselin in sitDBP

sitSBP

Average changes from baselini in sitSBP

Full Information

NCT ID

NCT01122251

First Posted

May 11, 2010

Last Updated

February 17, 2011

Sponsor

LG Life Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01122251

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

LG Life Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Hypertension

Keywords

hypertension, lercanidipine, valsartan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

441 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lercanidpine + Valsartan

Arm Type

Experimental

Arm Description

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

Arm Title

Lercanidipine or Valsartan

Arm Type

Active Comparator

Arm Description

L10, L20, V80, V160

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo comparators of Lercanidipine and Valsartan

Intervention Type

Drug

Intervention Name(s)

Lercanidipine + Valsartan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Lercanidipine or Valsartan

Intervention Description

L10, L20, V80, V160

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo of Lercanidipine and Valsartan

Primary Outcome Measure Information:

Title

sitDBP

Description

Average changes from baseline in sitDBP

Time Frame

Baseline, Week 8

Secondary Outcome Measure Information:

Title

sitDBP

Description

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

Time Frame

Week 4, 8

Title

sitDBP

Description

Average changes from baselin in sitDBP

Time Frame

Week 4

Title

sitSBP

Description

Average changes from baselini in sitSBP

Time Frame

Week 4, 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

23 sites in Korea

City

Seoul, Busan etc.

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Links:

URL

http://www.nlm.nih.gov/medlineplus/highbloodpressure.html

Description

High Blood Pressure

URL

http://www.mims.co.uk/Drugs/cardiovascular-system/hypertension/zanidip/

Description

Lercanidipine

URL

http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0137862534&QV1=VALSARTAN

Description

Valsartan

Learn more about this trial

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

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