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

Comparison of the Efficacy and Safety of Cilnidipine 10mg/Valsartan 160mg Combination Therapy, Cilnidipine 5mg/Valsartan 160mg Combination Therapy and Valsartan 160mg Monotherapy in Hypertensive Patients Inadequately Controlled With Valsartan 160mg Monotherapy: a Multicenter, Randomized, Double Blind Phase III Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02145104

Enrollment

286

Registered

2014-05-22

Start date

2014-06-17

Completion date

2016-09-29

Last updated

2018-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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

Interventions

DRUGvalsartan 160mg, cilnidipine 10mg, cilinidipine 5mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
change from baseline in mean sDBP	8 weeks

Secondary

Measure	Time frame
change from baseline in mean sDBP	4 weeks
change from baseline in mean sSBP	4, 8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026