Health TrialsbyHealthPanel

Phase II Clinical Study of HRS-9563 in Patients With Mild to Moderate Hypertension

ConditionMild to Moderate Hypertension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

This study aims to evaluate the efficacy and safety of HRS-9563 in patients with mild to moderate hypertension, and to explore its appropriate dosage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subject voluntarily signs the informed consent form.

Male or female, aged ≥ 18 years and ≤ 75 years;

Patients with mild to moderate hypertension;

At the Screening and Baseline periods, the mean sitting office systolic blood pressure is > 130 mmHg, and the 24-hour mean systolic blood pressure assessed by ABPM at Screening is ≥ 130 mmHg and < 160 mmHg.

Disqualifiers

Secondary hypertension;

Orthostatic hypotension;

Type 1 diabetes or poorly controlled type 2 diabetes;

Occurrence of any cardiovascular or cerebrovascular event within 6 months prior to screening;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-9563 Injection

    Drug

    HRS-9563 Injection

  • sodium chloride injection

    Drug

    sodium chloride injection

Treatment groups

234 Participants
are divided into 4 treatment groups
Group A: Treatment group A: HRS-9563 or Placebo Injection; low doseExperimental treatment 2 interventions
Group B: Treatment group B: HRS-9563 or Placebo Injection; Intermediate doseExperimental treatment 2 interventions
Group C: Treatment group C: HRS-9563 or Placebo Injection; Medium to high doseExperimental treatment 2 interventions
Group D: Treatment group D: HRS-9563 or Placebo Injection; high doseExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 6

Time frame
at 6 months after initiation of administration

Secondary outcomes

1

Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 3

Time frame
at 3 months after initiation of administration
2

Change from baseline in 24-hour mean systolic blood pressure assessed by ABPM at month 9

Time frame
at 9 months after initiation of administration
3

Change from baseline in 24-hour mean diastolic blood pressure assessed by ABPM at month 3

Time frame
at 3 months after initiation of administration
4

Change from baseline in 24-hour mean diastolic blood pressure assessed by ABPM at month 6

Time frame
at 6 months after initiation of administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Shengdi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now