Clinical Trial to Evaluate the Efficacy and Safety of Monotherapy Group of HL1113R1 or HL1113R2 Versus HL1113 (Fixed Dose Combination) in Patients With Essential Hypertension and Type II Diabetes Mellitus
Recruiting
Phase 3Interventional Study
HypertensionDiabete Type 2
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
228 (estimated)
Sponsor
Hanlim Pharm. Co., Ltd. · Industry
Who this trial is looking for
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This clinical trial is a randomized, active controlled, double blind, parallel, multi center, phase 3 study to evaluate the efficacy and safety of monotherapy group of HL1113R1 or HL1113R2 versus HL1113 (Fixed dose combination) in patients with essential hypertension and type II diabetes mellitus
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Adult male or female subjects aged ≥19 years at the time of written informed consent.
* Subjects diagnosed with essential hypertension accompanied by type 2 diabetes mellitus.
* etc.
Exclusion Criteria:
* Subjects whose blood pressure measured in the selected arm at both scr…
Inclusion Criteria:
* Adult male or female subjects aged ≥19 years at the time of written informed consent.
* Subjects diagnosed with essential hypertension accompanied by type 2 diabetes mellitus.
* etc.
Exclusion Criteria:
* Subjects whose blood pressure measured in the selected arm at both screening and randomization meets the following criterion: MSDBP ≥ 110 mmHg
* Subjects whose blood pressure measured three consecutive times in each arm at intervals of at least 2 minutes at screening shows a difference of ≥20 mmHg in SBP and ≥10 mmHg in DBP.
* etc.
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