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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01122251
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : February 18, 2011
Sponsor:
Information provided by:
LG Life Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Lercanidipine + Valsartan Drug: Lercanidipine or Valsartan Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 441 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lercanidpine + Valsartan
L10/V80, L20/V80, L10/V160, L20/V160
 Drug: Lercanidipine + Valsartan
L10/V80, L20/V80, L10/V160, L20/V160
Active Comparator: Lercanidipine or Valsartan
L10, L20, V80, V160
 Drug: Lercanidipine or Valsartan
L10, L20, V80, V160
Placebo Comparator: Placebo
Placebo comparators of Lercanidipine and Valsartan
 Drug: Placebo
Placebo of Lercanidipine and Valsartan


Outcome Measures
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Primary Outcome Measures :
  1. sitDBP [ Time Frame: Baseline, Week 8 ]
    Average changes from baseline in sitDBP


Secondary Outcome Measures :
  1. sitDBP [ Time Frame: Week 4, 8 ]
    Response rates (proportion of patients sitDBP<90mmHg or ≥10-mmHg reduction from baseline)

  2. sitDBP [ Time Frame: Week 4 ]
    Average changes from baselin in sitDBP

  3. sitSBP [ Time Frame: Week 4, 8 ]
    Average changes from baselini in sitSBP


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122251


Locations
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Korea, Republic of
23 sites in Korea
Seoul, Busan etc., Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
More Information
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Additional Information:

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Responsible Party: Kim, Sung Il / Assistant Manager, Clinical Trial 1 Team
ClinicalTrials.gov Identifier: NCT01122251    
Other Study ID Numbers: LG-ZVCL001
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: February 2011
Keywords provided by LG Life Sciences:
hypertension
lercanidipine
valsartan
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Lercanidipine
Antihypertensive Agents
 Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs