NCT02586311

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

October 23, 2015

Last Update Submit

October 4, 2016

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • The mean change of sitSBP(sitting Systolic blood pressure)

    From baseline at week 8

Secondary Outcomes (4)

  • 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

  • Blood Pressure Control rate

    From baseline to week 8

  • Blood Pressure Response rate

    From baseline to week 8

Study Arms (2)

CKD-330 16/5mg + Amlodipine 5mg placebo

EXPERIMENTAL

CKD-330 16/5mg + Amlodipine 5mg placebo, po, q.d.

Drug: CKD-330 16/5mgDrug: 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 PlaceboDrug: Amlodipine 5mg

Interventions

CKD-330 16/5mgDRUG

Once a day, 8 weeks

CKD-330 16/5mg + Amlodipine 5mg placebo
Amlodipine 5mg PlaceboDRUG

Once a day, 8 weeks

Also known as: Norvasc 5mg Placebo
CKD-330 16/5mg + Amlodipine 5mg placebo
CKD-330 16/5mg PlaceboDRUG

Once a day, 8 weeks

CKD-330 16/5mg placebo + Amlodipine 5mg
Amlodipine 5mgDRUG

Once a day, 8 weeks

Also known as: Norvasc 5mg
CKD-330 16/5mg placebo + Amlodipine 5mg

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Chang Gyu Park, M.D, Ph.D

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 26, 2015

Study Start

January 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

October 6, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)