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

This study has been completed.
Sponsor:
Information provided by:
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01122251
First received: May 11, 2010
Last updated: February 17, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Essential Hypertension
Drug: Lercanidipine + Valsartan
Drug: Lercanidipine or Valsartan
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • sitDBP [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    Average changes from baseline in sitDBP


Secondary Outcome Measures:
  • sitDBP [ Time Frame: Week 4, 8 ] [ Designated as safety issue: No ]
    Response rates (proportion of patients sitDBP<90mmHg or ≥10-mmHg reduction from baseline)

  • sitDBP [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Average changes from baselin in sitDBP

  • sitSBP [ Time Frame: Week 4, 8 ] [ Designated as safety issue: No ]
    Average changes from baselini in sitSBP


Estimated Enrollment: 441
Study Start Date: December 2009
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01122251

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

Additional Information:
No publications provided

Responsible Party: Kim, Sung Il / Assistant Manager, Clinical Trial 1 Team
ClinicalTrials.gov Identifier: NCT01122251     History of Changes
Other Study ID Numbers: LG-ZVCL001
Study First Received: May 11, 2010
Last Updated: February 17, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by LG Life Sciences:
hypertension
lercanidipine
valsartan

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Lercanidipine
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014