Efficacy and Safety of Lercanidipine and Valsartan in Patients With Essential Hypertension
Information source: LG Life Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension
Intervention: Lercanidipine + Valsartan (Drug); Lercanidipine or Valsartan (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: LG Life Sciences
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: sitDBP
Secondary outcome: sitDBPsitDBP sitSBP
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
23 sites in Korea, Seoul, Busan etc., Korea, Republic of
Seoul National University Hospital, Seoul, Korea, Republic of
Additional Information
High Blood Pressure Lercanidipine Valsartan
Starting date: December 2009
Last updated: February 17, 2011
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