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

LG Life Sciences

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Lercanidipine 10mg /Valsartan 160mg Placebo; Drug: Lercanidipine 10mg /Valsartan 160mg; Drug: Lercanidipin 10mg Placebo; Drug: Lercanidipine 10mg; Drug: Lercanidipine10mg /Valsartan 80mg; Drug: Lercanidipine10mg /Valsartan 80mg Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01928628

LG-ZVCL005

Details and patient eligibility

About

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

Enrollment: 449 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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449 participants in 3 patient groups

Lercanidipine 10mg

Active Comparator group

Description:

1 Tablet of Zanidip ® 10mg + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/V160 Placebo (8wks)

Treatment:

Drug: Lercanidipine 10mg /Valsartan 160mg Placebo

Drug: Lercanidipine 10mg

Drug: Lercanidipine10mg /Valsartan 80mg Placebo

Lercanidipine10mg /Valsartan 80mg

Experimental group

Description:

1 Tablet of Zanidip ® 10mg Placebo +1 Tablet of L10/V80 + 1 Tablet of L10/V160 Placebo (8wks)

Treatment:

Drug: Lercanidipine10mg /Valsartan 80mg

Drug: Lercanidipin 10mg Placebo

Drug: Lercanidipine 10mg /Valsartan 160mg Placebo

Lercanidipine 10mg /Valsartan 160mg

Experimental group

Description:

1 Tablet of Zanidip ® 10mg Placebo + 1 Tablet of L10/V80 Placebo + 1 Tablet of L10/ V160 (8wks)

Treatment:

Drug: Lercanidipin 10mg Placebo

Drug: Lercanidipine 10mg /Valsartan 160mg

Drug: Lercanidipine10mg /Valsartan 80mg Placebo