NCT02206165

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine combined or alone and select better dose of CKD-330 in essential hypertension patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
456

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

June 16, 2014

Last Update Submit

March 27, 2015

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • The mean change of sitDBP (sitting diastolic blood pressure)

    From baseline at week 8

Secondary Outcomes (4)

  • The mean change of sitDBP

    From baseline at week 4 and week 8

  • The mean change of sitSBP

    From baseline at week 4 and 8

  • Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg

    From baseline at week 4 and 8

  • Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg

    At week 4 and 8

Study Arms (8)

Candesartan 8mg + Amlodipine 5mg

EXPERIMENTAL

Candesartan 8mg + Amlodipine 5mg, po, q.d.

Drug: Candesartan 8mgDrug: Amlodipine 5mg

Candesartan 8mg + Amlodipine 10mg

EXPERIMENTAL

Candesartan 8mg + Amlodipine 10mg, po, q.d.

Drug: Candesartan 8mgDrug: Amlodipine 10mg

Candesartan 16mg + Amlodipine 5mg

EXPERIMENTAL

Candesartan 16mg + Amlodipine 5mg, po, q.d.

Drug: Candesartan 16mgDrug: Amlodipine 5mg

Candesartan 16mg + Amlodipine 10mg

EXPERIMENTAL

Candesartan 16mg + Amlodipine 10mg, po, q.d.

Drug: Candesartan 16mgDrug: Amlodipine 10mg

Candesartan 8mg

ACTIVE COMPARATOR

Candesartan 8mg, po, q.d.

Drug: Candesartan 8mg

Candesartan 16mg

ACTIVE COMPARATOR

Candesartan 16mg, po, q.d.

Drug: Candesartan 16mg

Amlodipine 5mg

ACTIVE COMPARATOR

Amlodipine 5mg, po, q.d.

Drug: Amlodipine 5mg

Amlodipine 10mg

ACTIVE COMPARATOR

Amlodipine 10mg, po, q.d.

Drug: Amlodipine 10mg

Interventions

Candesartan 8mgDRUG

Once a day, 8 weeks

Candesartan 8mgCandesartan 8mg + Amlodipine 10mgCandesartan 8mg + Amlodipine 5mg
Candesartan 16mgDRUG

Once a day, 8 weeks

Candesartan 16mgCandesartan 16mg + Amlodipine 10mgCandesartan 16mg + Amlodipine 5mg
Amlodipine 5mgDRUG

Once a day, 8 weeks

Amlodipine 5mgCandesartan 16mg + Amlodipine 5mgCandesartan 8mg + Amlodipine 5mg
Amlodipine 10mgDRUG

Once a day, 8 weeks

Amlodipine 10mgCandesartan 16mg + Amlodipine 10mgCandesartan 8mg + Amlodipine 10mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18 or above
  • Essential hypertension with 90mmHg ≤ mean sitDBP ≤ 115mmHg on target arm at Visit 3
  • Ability to provide written informed consent

You may not qualify if:

  • nean sitDBP ≥ 116mmHg or mean sitSBP ≥ 200mmHg at Visit 1, Visit 2, Visit 3
  • The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
  • Known or suspected Stage 2 Hypertension (aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
  • Patients with congestive heart failure(NYHA class III\~IV), ischemic heart disease, cardiomyopathy, heart valve disorder, arrhythmia, coronary artery bypass graft
  • History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
  • Type I Diabets Mellitus, Type II Diabetes Mellitus with HbA1c \> 8%
  • History of severe or malignant retinopathy
  • AST/ALT \> UNL \* 2, Serum Creatinine \> UNL \* 1.5, K \> 5.5mEq/L
  • Patients with acute or chronic inflammatory status, autoimmune disease
  • Patients who need to take antihypertensive drug besides Investigational products
  • Patients must be treated with medications prohibited for concomitant use during study period
  • Hypersensitive to Candesartan/Amlodipine or other dihydropyridine drugs
  • Hereditary angioedema or history of angioedema related to ACE inhibitor or angiotensin II receptor blockers
  • History of malignant tumor within 5 years
  • Patients who are dependent on drugs or alcohol
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Interventions

candesartanAmlodipine

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Cheol-Ho Kim, M.D., Ph.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HyunKyung Oh

CONTACT

82-2-2194-0469hkoh@ckdpharm.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2014

First Posted

August 1, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations

KR(1)