Efficacy/Safety of Cilnidipine Plus Valsartan Versus Valsartan in Patients With Hypertension

IlDong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02145104

ID_IDCV_1302

Details and patient eligibility

About

The purpose of this study is to evaluate of efficacy and safety of cilinidipine plus valsartan and valsartan alone in patients with essential hypertension inadequately controlled on valsartan monotherapy

Enrollment: 286 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• essential hypertension patients whose blood pressure is not controlled before the study (sDBP≥90mmHg for drug-treated patients, sDBP≥95mmHg for drug-naive patients)

Exclusion criteria

• sSBP≥80mmHg after 4weeks of valsartan 160mg treatment
• has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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286 participants in 3 patient groups

Arm A

Experimental group

Description:

cilinidpine 10mg + valsartan 160mg

Treatment:

Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg

Arm B

Experimental group

Description:

cilnidipine 5mg + valsartan 160mg

Treatment:

Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg

Arm C

Active Comparator group

Description:

valsartan 160mg

Treatment:

Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg