Efficacy and Safety of Lercanidipine and Valsartan in Pat... | NCT01122251

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

NCT01122251

Sponsor

LG Life Sciences

Status

Completed

Last Update Posted

Feb 18, 2011Estimated

Enrollment

441Estimated

Phase

Phase 2

Conditions

Essential Hypertension

Interventions

Lercanidipine + Valsartan
Lercanidipine or Valsartan
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

May 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

May 11, 2010

First Submission Date that Met QC Criteria

May 12, 2010

First Posted Date

May 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2011

Last Update Posted Date

Feb 18, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

441Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lercanidpine + Valsartan	Experimental	L10/V80, L20/V80, L10/V160, L20/V160	Drug: Lercanidipine + Valsartan
Lercanidipine or Valsartan	Active Comparator	L10, L20, V80, V160	Drug: Lercanidipine or Valsartan
Placebo	Placebo Comparator	Placebo comparators of Lercanidipine and Valsartan	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lercanidipine + Valsartan	Drug	L10/V80, L20/V80, L10/V160, L20/V160	Lercanidpine + Valsartan

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea
23 sites in Korea

Label	URL
High Blood Pressure	View source
Lercanidipine	View source
Valsartan

Condition Browse Module

MeSH Terms

ID	Term
D000075222	Essential Hypertension
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C060343	lercanidipine
D000068756	Valsartan

Ancestor Terms

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided