Efficacy/Safety of Cilnidipine Plus Valsartan Versus Vals... | NCT02145104

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

NCT02145104

Sponsor

IlDong Pharmaceutical Co Ltd

Status

Completed

Last Update Posted

Jun 13, 2018Actual

Enrollment

286Actual

Phase

Phase 3

Conditions

Hypertension

Interventions

valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

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 Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 17, 2014Actual

Primary Completion Date

Jun 7, 2016Actual

Completion Date

Sep 29, 2016Actual

First Submitted Date

May 20, 2014

First Submission Date that Met QC Criteria

May 20, 2014

First Posted Date

May 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2018

Last Update Posted Date

Jun 13, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

286Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg	Drug		Arm A Arm B Arm C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change from baseline in mean sDBP		8 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dong Ju Choi, M.D., Ph.D.	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Kyung-gi		South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068756	Valsartan
C065927	cilnidipine

Ancestor Terms

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided