Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01928628
First received: August 21, 2013
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

This study aims to compare and assess the efficacy and the safety of the combination agent of Lercanidipine and Valsartan and monotherapy of Lercanidipine alone in patients with essential hypertension


Condition Intervention Phase
Hypertension
Drug: Lercanidipine 10mg
Drug: Lercanidipine10mg /Valsartan 80mg
Drug: Lercanidipine 10mg /Valsartan 160mg
Drug: Lercanidipin 10mg Placebo
Drug: Lercanidipine10mg /Valsartan 80mg Placebo
Drug: Lercanidipine 10mg /Valsartan 160mg Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Parallel Design Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients Who Are Not Adequately Controlled on Lercanidipine 10mg Monotherapy.

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Change in mean sitDBP from week 0 to week 40 [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate at week 4 and 8 [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
    Proportion (%) of patients with mean sitDBP<90mmHg or proportion (%) of patients with mean reduction of sitDBP ≥10mmHg from week 0


Enrollment: 449
Study Start Date: May 2012
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lercanidipine 10mg
1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks)
Drug: Lercanidipine 10mg Drug: Lercanidipine10mg /Valsartan 80mg Placebo Drug: Lercanidipine 10mg /Valsartan 160mg Placebo
Experimental: Lercanidipine10mg /Valsartan 80mg
1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks)
Drug: Lercanidipine10mg /Valsartan 80mg Drug: Lercanidipin 10mg Placebo Drug: Lercanidipine 10mg /Valsartan 160mg Placebo
Experimental: Lercanidipine 10mg /Valsartan 160mg
1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks)
Drug: Lercanidipine 10mg /Valsartan 160mg Drug: Lercanidipin 10mg Placebo Drug: Lercanidipine10mg /Valsartan 80mg Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged ≥ 20 to ≤75 years old
  • Patient with essential hypertension

Exclusion Criteria:

  • When the BP level measured at screening was sitDBP>120 mmHg or sitSBP >180 mmHg
  • Patient with difference in repeatedly measured blood pressures from the selected arm at screening was sitSBP≥ 20mmHg or sitDBP ≥ 10mmHg
  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: NCT01928628

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01928628     History of Changes
Other Study ID Numbers: LG-ZVCL005
Study First Received: August 21, 2013
Last Updated: August 27, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on July 23, 2014