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

June 11, 2018 updated by: IlDong Pharmaceutical Co Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline in mean sDBP
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IlDong Pharmaceutical Co Ltd

Investigators

  • Principal Investigator: Dong Ju Choi, M.D., Ph.D., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2014

Primary Completion (Actual)

June 7, 2016

Study Completion (Actual)

September 29, 2016

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 22, 2014

Study Record Updates

Last Update Posted (Actual)

June 13, 2018

Last Update Submitted That Met QC Criteria

June 11, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID_IDCV_1302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe