Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension

Handok

Status and phase: Completed; Phase 2

Conditions: Essential Hypertension

Treatments: Drug: Irbesartan/Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04488978

AI-C201

Details and patient eligibility

About

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

Enrollment: 440 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Orthostatic hypertension with symptom
• Other exclusion applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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440 participants in 8 patient groups

Irbesartan low/Amlodipine low

Experimental group

Description:

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

Treatment:

Drug: Irbesartan/Amlodipine

Irbesartan low/Amlodipine high

Experimental group

Description:

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

Treatment:

Drug: Irbesartan/Amlodipine

Irbesartan high/Amlodipine low

Experimental group

Description:

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

Treatment:

Drug: Irbesartan/Amlodipine

Irbesartan high/Amlodipine high

Experimental group

Description:

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

Treatment:

Drug: Irbesartan/Amlodipine

Amlodipine low

Active Comparator group

Description:

Amlodipine low, once daily for 8 weeks

Treatment:

Drug: Irbesartan/Amlodipine

Amlodipine high

Active Comparator group

Description:

Amlodipine high, once daily for 8 weeks

Treatment:

Drug: Irbesartan/Amlodipine

Irbesartan low

Active Comparator group

Description:

Irbesartan low, once daily for 8 weeks

Treatment:

Drug: Irbesartan/Amlodipine

Irbesartan high

Active Comparator group

Description:

Irbesartan high, once daily for 8 weeks

Treatment:

Drug: Irbesartan/Amlodipine