Efficacy and Safety of Lercanidipine and Valsartan in Patients With Essential Hypertension

Phase 2

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Lercanidipine + Valsartan; Drug: Placebo; Drug: Lercanidipine or Valsartan

• Registration Number: NCT01122251
• Lead Sponsor: LG Life Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2010-05
• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-13
• Study Completion: 2010-07
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-17
• Last Update Posted: 2011-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Lercanidpine + Valsartan	Lercanidipine + Valsartan	L10/V80, L20/V80, L10/V160, L20/V160
Placebo	Placebo	Placebo comparators of Lercanidipine and Valsartan
Lercanidipine or Valsartan	Lercanidipine or Valsartan	L10, L20, V80, V160

Primary Outcome Measures

Name	Time	Method
sitDBP	Baseline, Week 8	Average changes from baseline in sitDBP

Secondary Outcome Measures

Name	Time	Method
sitSBP	Week 4, 8	Average changes from baselini in sitSBP
sitDBP	Week 4	Average changes from baselin in sitDBP

Trial Locations

Locations (2)

23 sites in Korea; 🇰🇷 Seoul, Busan etc., Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of