- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05475665
Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients
August 15, 2023 updated by: Handok Inc.
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
157
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Hanyang University Seoul Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Irbesartan
|
Irbesartan once daily for 8 weeks
|
Experimental: Irbesartan/Amlodipine
|
Irbesartan/Amlodipine once daily for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in mean sitting systolic blood pressure (mmHg)
Time Frame: Week 8
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Responder rate
Time Frame: Week 4, 8
|
Week 4, 8
|
Change form baseline in mean sitting systolic blood pressure (mmHg)
Time Frame: Week 4
|
Week 4
|
Change form baseline in mean sitting diastolic blood pressure (mmHg)
Time Frame: Week 4, 8
|
Week 4, 8
|
Target blood pressure reach rate
Time Frame: Week 4, 8
|
Week 4, 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 14, 2022
Primary Completion (Actual)
March 30, 2023
Study Completion (Actual)
June 13, 2023
Study Registration Dates
First Submitted
July 24, 2022
First Submitted That Met QC Criteria
July 24, 2022
First Posted (Actual)
July 27, 2022
Study Record Updates
Last Update Posted (Actual)
August 18, 2023
Last Update Submitted That Met QC Criteria
August 15, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Essential Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Irbesartan
Other Study ID Numbers
- HD-AI-302
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Essential Hypertension
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Addpharma Inc.Completed
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
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BayerCompletedHypertension, EssentialGermany
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
Addpharma Inc.Not yet recruitingHypertension,Essential
-
Instituto de Cardiologia do Rio Grande do SulRecruitingHypertension | Hypertension,EssentialBrazil
-
Federal University of Health Science of Porto AlegreIrmandade Santa Casa de Misericórdia de Porto Alegre; Leonhardt Ventures LLCNot yet recruitingHypertension | Hypertension,Essential
Clinical Trials on Irbesartan/Amlodipine
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SanofiCompleted
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Handok Inc.CompletedEssential HypertensionKorea, Republic of
-
SanofiCompletedHypertensionIndia, Philippines, Taiwan, Korea, Republic of
-
SanofiCompletedIrbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy (I-ADD)HypertensionMorocco, Brazil, Colombia, Guatemala, Mexico, Tunisia, United Arab Emirates, Venezuela
-
Handok Inc.CompletedHealthy VolunteersKorea, Republic of
-
SanofiCompletedHypertensionBrazil, Chile, Colombia, Egypt, Lebanon, Mexico, Morocco, Tunisia, Venezuela
-
Handok Inc.CompletedHealthy VolunteersKorea, Republic of
-
Handok Inc.CompletedHealthy VolunteersKorea, Republic of
-
Handok Inc.CompletedEssential HypertensionKorea, Republic of
-
Assistance Publique - Hôpitaux de ParisCompleted