NCT04488978

Brief Summary

A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension

Trial Health

87
On Track

Trial Health Score

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

Enrollment
440

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2

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

May 21, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2021

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

1.5 years

First QC Date

July 21, 2020

Last Update Submit

June 28, 2022

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • The change in MSSBP between baseline and Week8.

    The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8.

    Baseline and Week8

Secondary Outcomes (3)

  • The change in MSSBP between baseline and Week4.

    Baseline and Week4

  • The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8.

    Baseline and Week4/8

  • The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8.

    Baseline and Week4/8

Study Arms (8)

Irbesartan low/Amlodipine low

EXPERIMENTAL

Irbesartan low \& Amlodipine low, once daily for 8 weeks

Drug: Irbesartan/Amlodipine

Irbesartan low/Amlodipine high

EXPERIMENTAL

Irbesartan low \& Amlodipine high, once daily for 8 weeks

Drug: Irbesartan/Amlodipine

Irbesartan high/Amlodipine low

EXPERIMENTAL

Irbesartan high \& Amlodipine low, once daily for 8 weeks

Drug: Irbesartan/Amlodipine

Irbesartan high/Amlodipine high

EXPERIMENTAL

Irbesartan high \& Amlodipine high, once daily for 8 weeks

Drug: Irbesartan/Amlodipine

Amlodipine low

ACTIVE COMPARATOR

Amlodipine low, once daily for 8 weeks

Drug: Irbesartan/Amlodipine

Amlodipine high

ACTIVE COMPARATOR

Amlodipine high, once daily for 8 weeks

Drug: Irbesartan/Amlodipine

Irbesartan low

ACTIVE COMPARATOR

Irbesartan low, once daily for 8 weeks

Drug: Irbesartan/Amlodipine

Irbesartan high

ACTIVE COMPARATOR

Irbesartan high, once daily for 8 weeks

Drug: Irbesartan/Amlodipine

Interventions

Irbesartan/AmlodipineDRUG

QID

Amlodipine highAmlodipine lowIrbesartan highIrbesartan high/Amlodipine highIrbesartan high/Amlodipine lowIrbesartan lowIrbesartan low/Amlodipine highIrbesartan low/Amlodipine low

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are 19 years or older / 75 years or younger on screening
  • Signed informed consent
  • Patients with Essential Hypertension

You may not qualify if:

  • Orthostatic hypertension with symptom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

IrbesartanAmlodipine

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsDihydropyridinesPyridines

Study Design

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

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 28, 2020

Study Start

May 21, 2020

Primary Completion

November 9, 2021

Study Completion

November 9, 2021

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations

KR(1)