CKD-330 Phase 3 Trial in Amlodipine Non-responder

October 4, 2016 updated by: Chong Kun Dang Pharmaceutical

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a CKD-330 Versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy

Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy

Study Type

Interventional

Enrollment (Actual)

160

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

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of 19 or above
  • Essential hypertension with 140mmHg ≤ mean sitSBP < 180mmHg on target arm at Visit 2
  • Ability to provide written informed consent

Exclusion Criteria:

  • The difference between arms of sitSBP ≥ 20mmHg and/or sitDBP ≥ 10mmHg at Visit 1
  • mean sitSBP ≥ 200mmHg and/or mean sitDBP ≥ 120mmHg on target arm at Visit 1
  • mean sitSBP ≥ 180mmHg and/or mean sitDBP ≥ 120mmHg on target arm at Visit 2
  • Known or suspected Secondary Hypertension
  • Type I Diabetes Mellitus and Type II Diabetes Mellitus with HbA1c > 9%
  • Patients with severe congestive heart failure(NYHA class III, IV)
  • Patient with ischemic heart disease, Ischemic cardiovascular disease, Valvular heart disease, arrhythmia requiring treatment within 3 months
  • History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
  • History of severe or malignant retinopathy
  • AST/ALT ≥ UNL*3, Serum creatinine ≥ UNL*1.5, K > 5.5mEq/L
  • Patients with acute or chronic inflammatory status requiring treatment
  • Patient who need to take antihypertensive drug besides Investigational products
  • Patient must be treated with medications prohibited for concomitant use during the study period
  • History of angioedema related to ACE inhibitor or angiotensin II receptor blockers
  • History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
  • History of malignant tumor within 5 years
  • Patient who are dependent on drugs or alcohol within 6 months
  • Hypersensitive to Candesartan/Amlodipine
  • Women with pregnant, breast-feeding
  • Patients treated with other investigational product within 30 days at first time taking the investigational product
  • Not eligible to participate for the study at the discretion of investigator

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: CKD-330 16/5mg + Amlodipine 5mg placebo
CKD-330 16/5mg + Amlodipine 5mg placebo, po, q.d.
Drug: CKD-330 16/5mg
Once a day, 8 weeks
Drug: Amlodipine 5mg Placebo
Once a day, 8 weeks
Other Names:
  • Norvasc 5mg Placebo
Active Comparator: CKD-330 16/5mg placebo + Amlodipine 5mg
CKD-330 16/5mg placebo + Amlodipine 5mg, po, q.d.
Drug: Amlodipine 5mg
Once a day, 8 weeks
Other Names:
  • Norvasc 5mg
Drug: CKD-330 16/5mg Placebo
Once a day, 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean change of sitSBP(sitting Systolic blood pressure)
Time Frame: From baseline at week 8
From baseline at week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mean change of sitSBP(sitting Systolic blood pressure)
Time Frame: From baseline at week 4
From baseline at week 4
The mean change of sitDBP(sitting diastolic blood pressure)
Time Frame: From baseline at week 4 and week 8
From baseline at week 4 and week 8
Blood Pressure Control rate
Time Frame: From baseline to week 8
Patient achieving sitSBP < 140mmHg and sitDBP < 90mmHg
From baseline to week 8
Blood Pressure Response rate
Time Frame: From baseline to week 8
sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg
From baseline to week 8

Collaborators and Investigators

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

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Chang Gyu Park, M.D, Ph.D, Korea University Guro 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

January 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 144HT15027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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