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

NCT ID: NCT01928628

Last Updated: 2013-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

449 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lercanidipine 10mg

1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks)

Group Type ACTIVE_COMPARATOR

Lercanidipine 10mg

Intervention Type DRUG

Lercanidipine10mg /Valsartan 80mg Placebo

Intervention Type DRUG

Lercanidipine 10mg /Valsartan 160mg Placebo

Intervention Type DRUG

Lercanidipine10mg /Valsartan 80mg

1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks)

Group Type EXPERIMENTAL

Lercanidipine10mg /Valsartan 80mg

Intervention Type DRUG

Lercanidipin 10mg Placebo

Intervention Type DRUG

Lercanidipine 10mg /Valsartan 160mg Placebo

Intervention Type DRUG

Lercanidipine 10mg /Valsartan 160mg

1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks)

Group Type EXPERIMENTAL

Lercanidipine 10mg /Valsartan 160mg

Intervention Type DRUG

Lercanidipin 10mg Placebo

Intervention Type DRUG

Lercanidipine10mg /Valsartan 80mg Placebo

Intervention Type DRUG

Interventions

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Lercanidipine 10mg

Intervention Type DRUG

Lercanidipine10mg /Valsartan 80mg

Intervention Type DRUG

Lercanidipine 10mg /Valsartan 160mg

Intervention Type DRUG

Lercanidipin 10mg Placebo

Intervention Type DRUG

Lercanidipine10mg /Valsartan 80mg Placebo

Intervention Type DRUG

Lercanidipine 10mg /Valsartan 160mg Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LG Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Na SH, Lee HY, Hong Baek S, Jeon HK, Kang JH, Kim YN, Park CG, Ryu JK, Rhee MY, Kim MH, Hong TJ, Choi DJ, Cho SW, Cha DH, Jeon ES, Kim JJ, Shin JH, Park SH, Lee SH, John SH, Shin ES, Kim NH, Lee SY, Kwan J, Jeong MH, Kim SW, Jeong JO, Kim DW, Lee NH, Park WJ, Ahn JC, Won KH, Uk Lee S, Cho JH, Kim SK, Ahn T, Hong S, Yoo SY, Kim SY, Kim BS, Juhn JH, Kim SY, Lee YJ, Oh BH. Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial. Clin Ther. 2015 Aug;37(8):1726-39. doi: 10.1016/j.clinthera.2015.05.512. Epub 2015 Jul 8.

Reference Type DERIVED
PMID: 26164786 (View on PubMed)

Other Identifiers

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LG-ZVCL005

Identifier Type: -

Identifier Source: org_study_id