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

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ClinicalTrials.gov Identifier: NCT01928628
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : May 2012
Actual Primary Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change in mean sitDBP from week 0 to week 40 [ Time Frame: 40 weeks ]

Secondary Outcome Measures :
  1. Response rate at week 4 and 8 [ Time Frame: 4 weeks and 8 weeks ]
    Proportion (%) of patients with mean sitDBP<90mmHg or proportion (%) of patients with mean reduction of sitDBP ≥10mmHg from week 0



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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 ≥ 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

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): NCT01928628


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