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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:

sitDBP

sitDBP

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

Page last updated: August 20, 2015

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