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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Lercanidipine 10mg; Drug: Lercanidipine 10mg /Valsartan 160mg; Drug: Lercanidipine10mg /Valsartan 80mg; Drug: Lercanidipine10mg /Valsartan 80mg Placebo; Drug: Lercanidipin 10mg Placebo; Drug: Lercanidipine 10mg /Valsartan 160mg Placebo

• Registration Number: NCT01928628
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2013-04
• Status Verified: 2013-08
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-21
• Study First Posted: 2013-08-27
• Last Update Submitted: 2013-08-27
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 449

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lercanidipine 10mg	Lercanidipine 10mg	1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks)
Lercanidipine10mg /Valsartan 80mg	Lercanidipine 10mg /Valsartan 160mg Placebo	1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks)
Lercanidipine 10mg /Valsartan 160mg	Lercanidipine 10mg /Valsartan 160mg	1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks)
Lercanidipine 10mg	Lercanidipine10mg /Valsartan 80mg Placebo	1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks)
Lercanidipine 10mg	Lercanidipine 10mg /Valsartan 160mg Placebo	1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks)
Lercanidipine10mg /Valsartan 80mg	Lercanidipine10mg /Valsartan 80mg	1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks)
Lercanidipine10mg /Valsartan 80mg	Lercanidipin 10mg Placebo	1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks)
Lercanidipine 10mg /Valsartan 160mg	Lercanidipin 10mg Placebo	1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks)
Lercanidipine 10mg /Valsartan 160mg	Lercanidipine10mg /Valsartan 80mg Placebo	1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks)

Primary Outcome Measures

Name	Time	Method
Change in mean sitDBP from week 0 to week 40	40 weeks

Secondary Outcome Measures

Name	Time	Method
Response rate at week 4 and 8	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of