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

August 21, 2013
August 27, 2013
May 2012
April 2013   (final data collection date for primary outcome measure)
Change in mean sitDBP from week 0 to week 40 [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01928628 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients
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.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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
  • Active Comparator: Lercanidipine 10mg
    1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks)
    Interventions:
    • 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)
    Interventions:
    • 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)
    Interventions:
    • Drug: Lercanidipine 10mg /Valsartan 160mg
    • Drug: Lercanidipin 10mg Placebo
    • Drug: Lercanidipine10mg /Valsartan 80mg Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
449
Not Provided
April 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01928628
LG-ZVCL005
No
LG Life Sciences
LG Life Sciences
Not Provided
Not Provided
LG Life Sciences
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP