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CompletedNCT02145104Updated Jun 13, 2018

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

A Phase 3 interventional study of valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg in Hypertension, sponsored by IlDong Pharmaceutical Co Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-06-13.

Sponsored by IlDong Pharmaceutical Co Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
286
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 286 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

IlDong Pharmaceutical Co Ltd is the lead sponsor of 49 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • sSBP≥80mmHg after 4weeks of valsartan 160mg treatment
  • has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
286 participants (actual)

Study arms

  • Experimental
    Arm A

    cilinidpine 10mg + valsartan 160mg

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

  • Experimental
    Arm B

    cilnidipine 5mg + valsartan 160mg

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

  • Active comparator
    Arm C

    valsartan 160mg

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

Interventions

  • Drugvalsartan 160mg, cilnidipine 10mg, cilinidipine 5mg
06

What researchers measure

Primary outcomes

  1. change from baseline in mean sDBP

    Time frame: 8 weeks

Secondary outcomes

  1. change from baseline in mean sDBP

    Time frame: 4 weeks

  2. change from baseline in mean sSBP

    Time frame: 4, 8 weeks

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam-si, Kyung-gi, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02145104
Lead sponsor
IlDong Pharmaceutical Co Ltd
Responsible party
Sponsor
First posted
May 22, 2014
Start date
Jun 17, 2014
Primary completion
Jun 7, 2016
Completion
Sep 29, 2016
Last update
Jun 13, 2018

Study contacts

Dong Ju Choi, M.D., Ph.D.
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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