Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients

• Sponsor: Handok Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05475665
• Collaborator: (none)
• Enrollment: 168
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.6
• Patients Per Site Per Month: 15.9

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: Irbesartan/Amlodipine; Drug: Irbesartan	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase # Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients
• Actual Study Start Date: Jul 14, 2022
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Irbesartan/Amlodipine	Drug: Irbesartan/Amlodipine; Irbesartan/Amlodipine once daily for 8 weeks
Active Comparator: Irbesartan	Drug: Irbesartan; Irbesartan once daily for 8 weeks

Outcome Measures

Primary Outcome Measures

1. Change from baseline in mean sitting systolic blood pressure (mmHg) [Week 8]

Secondary Outcome Measures

1. Change form baseline in mean sitting systolic blood pressure (mmHg) [Week 4]

2. Change form baseline in mean sitting diastolic blood pressure (mmHg) [Week 4, 8]

3. Responder rate [Week 4, 8]

4. Target blood pressure reach rate [Week 4, 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who are 19 years or older on screening

• Signed informed consent

• Patients with Essential Hypertension

• Other inclusion applied

Exclusion Criteria:

• Orthostatic hypotension with symptom

• Other exclusion applied

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanyang University Seoul Hospital	Seoul		Korea, Republic of

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: NCT05475665
• Other Study ID Numbers: HD-AI-302
• First Posted: Jul 27, 2022
• Last Update Posted: Jul 27, 2022
• Last Verified: Jul 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 Jul 27, 2022