NCT02651870

Brief Summary

A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Apr 2015

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

Study Start

First participant enrolled

April 22, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2016

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2016

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

10 months

First QC Date

January 8, 2016

Last Update Submit

August 23, 2020

Conditions

Hypertension

Keywords

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 to week 4

  • The mean change of sitSBP

    From baseline to week 4 and 8

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

    From baseline to week 8

  • Response rate: sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg

    From baseline to week 8

Study Arms (3)

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 16mg

ACTIVE COMPARATOR

Candesartan 16mg, po, q.d.

Drug: Candesartan 16mg

Interventions

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

Eligibility Criteria

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

You may qualify if:

  • Age of 19 or above
  • Inadequately controlled Essential hypertension at Screening
  • Drug naive or didn't take antihypertensive drug within 2 weeks prior to Visit 1
  • Mean sitDBP ≥ 95mmHg on target arm
  • Taking antihypertensive drug but not controlled
  • Mean sitDBP ≥ 90mmHg on target arm
  • Inadequately controlled after 4 weeks of Candesartan 16mg monotherapy
  • Mean sitDBP at Visit 2 ≥ 90mmHg on target arm
  • Ability to provide written informed consent

You may not qualify if:

  • The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
  • Mean sitDBP ≥ 120mmHg or mean sitSBP ≥ 200mmHg on target arm at Visit 1 and Visit 2
  • Known to suspected Stage 2 Hypertension(aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
  • Patient with congestive heart failure(NYHA class III, IV)
  • Patient with unstable angina pectoris, myocardial infarction, Valvular heart disease, arrhythmia(treatment required) within 3 months
  • History of stroke, cerebral hemorrhage within 6 months
  • Type I Diabetes mellitus, Type II Diabetes mellitus with HbA1c \> 8.5%
  • History of severe or malignant retinopathy
  • AST/ALT \> UNL\*3, Serum creatinine \> UNL\*1.5, K \> 5.5mEq/L
  • Patient with acute or chronic inflammatory(treatment required) status
  • 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
  • Hypersensitive to Candesartan/Amlodipine
  • Patient who are dependent on drugs or alcohol within 6 months
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

candesartanAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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

January 8, 2016

First Posted

January 11, 2016

Study Start

April 22, 2015

Primary Completion

February 25, 2016

Study Completion

February 29, 2016

Last Updated

August 25, 2020

Record last verified: 2020-08

Locations

KR(1)