NCT02145104

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Jun 2014

Typical duration for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

June 17, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2016

Completed
Last Updated

June 13, 2018

Status Verified

June 1, 2018

Enrollment Period

2 years

First QC Date

May 20, 2014

Last Update Submit

June 11, 2018

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • change from baseline in mean sDBP

    8 weeks

Secondary Outcomes (2)

  • change from baseline in mean sDBP

    4 weeks

  • change from baseline in mean sSBP

    4, 8 weeks

Study Arms (3)

Arm A

EXPERIMENTAL

cilinidpine 10mg + valsartan 160mg

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

Arm B

EXPERIMENTAL

cilnidipine 5mg + valsartan 160mg

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

Arm C

ACTIVE COMPARATOR

valsartan 160mg

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

Interventions

valsartan 160mg, cilnidipine 10mg, cilinidipine 5mgDRUG
Arm AArm BArm C

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Kyung-gi, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartancilnidipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Dong Ju Choi, M.D., Ph.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

June 17, 2014

Primary Completion

June 7, 2016

Study Completion

September 29, 2016

Last Updated

June 13, 2018

Record last verified: 2018-06

Locations

KR(1)