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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg

• Registration Number: NCT02145104
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-22
• Study Start: 2014-06-17
• Primary Completion: 2016-06-07
• Study Completion: 2016-09-29
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm C	valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg	valsartan 160mg
Arm A	valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg	cilinidpine 10mg + valsartan 160mg
Arm B	valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg	cilnidipine 5mg + valsartan 160mg

Primary Outcome Measures

Name	Time	Method
change from baseline in mean sDBP	8 weeks

Secondary Outcome Measures

Name	Time	Method
change from baseline in mean sDBP	4 weeks
change from baseline in mean sSBP	4, 8 weeks

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Kyung-gi, Korea, Republic of