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

• Sponsor: Handok Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04488978
• Collaborator: (none)
• Enrollment: 440
• Location: 1
• Arms: 8
• Actual Duration (Months): 17.6
• Patients Per Site Per Month: 24.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: Irbesartan/Amlodipine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 440 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: May 21, 2020
• Actual Primary Completion Date: Nov 9, 2021
• Actual Study Completion Date: Nov 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Irbesartan low/Amlodipine low Irbesartan low & Amlodipine low, once daily for 8 weeks	Drug: Irbesartan/Amlodipine; QID
Experimental: Irbesartan low/Amlodipine high Irbesartan low & Amlodipine high, once daily for 8 weeks	Drug: Irbesartan/Amlodipine; QID
Experimental: Irbesartan high/Amlodipine low Irbesartan high & Amlodipine low, once daily for 8 weeks	Drug: Irbesartan/Amlodipine; QID
Experimental: Irbesartan high/Amlodipine high Irbesartan high & Amlodipine high, once daily for 8 weeks	Drug: Irbesartan/Amlodipine; QID
Active Comparator: Amlodipine low Amlodipine low, once daily for 8 weeks	Drug: Irbesartan/Amlodipine; QID
Active Comparator: Amlodipine high Amlodipine high, once daily for 8 weeks	Drug: Irbesartan/Amlodipine; QID
Active Comparator: Irbesartan low Irbesartan low, once daily for 8 weeks	Drug: Irbesartan/Amlodipine; QID
Active Comparator: Irbesartan high Irbesartan high, once daily for 8 weeks	Drug: Irbesartan/Amlodipine; QID

Outcome Measures

Primary Outcome Measures

1. The change in MSSBP between baseline and Week8. [Baseline and Week8]

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

Secondary Outcome Measures

1. The change in MSSBP between baseline and Week4. [Baseline and Week4]

2. The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8. [Baseline and Week4/8]

3. The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8. [Baseline and Week4/8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

• Handok Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Handok Inc.
• ClinicalTrials.gov Identifier: NCT04488978
• Other Study ID Numbers: AI-C201
• First Posted: Jul 28, 2020
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Amlodipine; Irbesartan

Study Results

No Results Posted as of Jun 30, 2022