Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients
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.
1 other identifier
interventional
449
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 21, 2013
CompletedFirst Posted
Study publicly available on registry
August 27, 2013
CompletedAugust 28, 2013
August 1, 2013
11 months
August 21, 2013
August 27, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change in mean sitDBP from week 0 to week 40
40 weeks
Secondary Outcomes (1)
Response rate at week 4 and 8
4 weeks and 8 weeks
Study Arms (3)
Lercanidipine 10mg
ACTIVE COMPARATOR1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks)
Lercanidipine10mg /Valsartan 80mg
EXPERIMENTAL1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks)
Lercanidipine 10mg /Valsartan 160mg
EXPERIMENTAL1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks)
Interventions
Eligibility Criteria
You may qualify if:
- Patients aged ≥ 20 to ≤75 years old
- Patient with essential hypertension
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Life Scienceslead
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 26164786DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2013
First Posted
August 27, 2013
Study Start
May 1, 2012
Primary Completion
April 1, 2013
Last Updated
August 28, 2013
Record last verified: 2013-08