Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy

Chong Kun Dang

Status and phase: Enrolling; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: D012, placebo of D064, placebo of D701; Drug: D064, D701, placebo of D012

Study type: Interventional

Funder types: Industry

Identifiers

NCT05526703

A30_14HT2209

Details and patient eligibility

About

Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy.

Enrollment: 108 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who are 19 years old or older.
2. Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.

Exclusion criteria

1. Subjects with a history of secondary hypertension or suspected secondary hypertension
2. Subjects who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period
3. Subjects with hypersensitivity or history of clinical trial drugs and similar drugs
4. Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
5. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
6. Subjects who received other clinical trial drugs within 4 weeks of screening visit.
7. Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug
8. Subjects who are unable to participate in this clinical trial at the discretion of the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

Experimental Group

Experimental group

Treatment:

Drug: D064, D701, placebo of D012

Comparator Group

Active Comparator group

Treatment:

Drug: D012, placebo of D064, placebo of D701