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

NCT ID: NCT02145104

Last Updated: 2018-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-17

Study Completion Date

2016-09-29

Brief Summary

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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

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A

cilinidpine 10mg + valsartan 160mg

Group Type EXPERIMENTAL

valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg

Intervention Type DRUG

Arm B

cilnidipine 5mg + valsartan 160mg

Group Type EXPERIMENTAL

valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg

Intervention Type DRUG

Arm C

valsartan 160mg

Group Type ACTIVE_COMPARATOR

valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg

Intervention Type DRUG

Interventions

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valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dong Ju Choi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Kyung-gi, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ID_IDCV_1302

Identifier Type: -

Identifier Source: org_study_id

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