Efficacy and Safety of Lercanidipine and Valsartan in Patients With Essential Hypertension
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
1 other identifier
interventional
441
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2009
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 11, 2010
CompletedFirst Posted
Study publicly available on registry
May 13, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFebruary 18, 2011
February 1, 2011
5 months
May 11, 2010
February 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sitDBP
Average changes from baseline in sitDBP
Baseline, Week 8
Secondary Outcomes (3)
sitDBP
Week 4, 8
sitDBP
Week 4
sitSBP
Week 4, 8
Study Arms (3)
Lercanidpine + Valsartan
EXPERIMENTALL10/V80, L20/V80, L10/V160, L20/V160
Lercanidipine or Valsartan
ACTIVE COMPARATORL10, L20, V80, V160
Placebo
PLACEBO COMPARATORPlacebo comparators of Lercanidipine and Valsartan
Interventions
Eligibility Criteria
You may qualify if:
- Patients aged between 20 and 75
- Essential hypertension at screening (-3 week)
- Randomization Criteria:
- Essential hypertension at baseline (90mmHg≤sitDBP≤109mmHg, except sitSBP≥180)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Life Scienceslead
Study Sites (2)
Seoul National University Hospital
Seoul, South Korea
23 sites in Korea
Seoul, Busan Etc., South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 11, 2010
First Posted
May 13, 2010
Study Start
December 1, 2009
Primary Completion
May 1, 2010
Study Completion
July 1, 2010
Last Updated
February 18, 2011
Record last verified: 2011-02