CKD-330 Phase 3 Trial in Amlodipine Non-responder | NCT02586311

Studies
CKD-330 Phase 3 Trial in Amlodipine Non-responder

NCT02586311

Sponsor

Chong Kun Dang Pharmaceutical

Status

Completed

Last Update Posted

Oct 6, 2016Estimated

Enrollment

160Actual

Phase

Phase 3

Conditions

Hypertension

Interventions

CKD-330 16/5mg
Amlodipine 5mg Placebo
CKD-330 16/5mg Placebo
Amlodipine 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

Status Module

Record Verification Date

Oct 2016

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

Jan 2016

Primary Completion Date

Aug 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Oct 23, 2015

First Submission Date that Met QC Criteria

Oct 23, 2015

First Posted Date

Oct 26, 2015Estimated

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

Oct 4, 2016

Last Update Posted Date

Oct 6, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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

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

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

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CKD-330 16/5mg + Amlodipine 5mg placebo	Experimental	CKD-330 16/5mg + Amlodipine 5mg placebo, po, q.d.	Drug: CKD-330 16/5mg Drug: Amlodipine 5mg Placebo
CKD-330 16/5mg placebo + Amlodipine 5mg	Active Comparator	CKD-330 16/5mg placebo + Amlodipine 5mg, po, q.d.	Drug: CKD-330 16/5mg Placebo Drug: Amlodipine 5mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CKD-330 16/5mg	Drug	Once a day, 8 weeks	CKD-330 16/5mg + Amlodipine 5mg placebo

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

Measure	Description	Time Frame
The mean change of sitSBP(sitting Systolic blood pressure)		From baseline at week 4
The mean change of sitDBP(sitting diastolic blood pressure)		From baseline at week 4 and week 8

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds