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A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.

ConditionUncontrolled or Resistant Hypertension
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

The study is being conducted to evaluate the efficacy and safety of HRS-1780 in participants with uncontrolled hypertension or resistant hypertension. To explore the optimal use of HRS-1780 in participants with uncontrolled hypertension or resistant hypertension。

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged ≥ 18 and < 80 years ；

Mean trough seated SBP ≥ 140 mmHg and < 170 mmHg at both screening and randomization visits.

Meet the criteria for uncontrolled hypertension；

Meet the criteria for resistant hypertension；

Disqualifiers

Mean trough seated DBP ≥ 110 mmHg at randomization.

Have a known secondary cause of hypertension, including but not limited to: renal artery stenosis, coarctation of the aorta, uncontrolled or untreated hyperthyroidism/hypothyroidism, pheochromocytoma, or Cushing's syndrome.

History of adrenal insufficiency at screening.

Presence of severe structural heart disease at screening, including severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, rheumatic heart disease, or congenital heart disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-1780 tablet

    Drug

    HRS-1780 tablet Dose 1

  • HRS-1780 tablet

    Drug

    HRS-1780 tablet Dose 2

  • HRS-1780 tablet

    Drug

    HRS-1780 tablet Dose 3

  • HRS-1780 tablet placebo

    Drug

    HRS-1780 tablet placebo

Treatment groups

914 Participants
are divided into 4 treatment groups
Group A: Treatment group A: HRS-1780 tablet Dose 1Experimental treatment 1 intervention
Group B: Treatment group B: HRS-1780 tablet Dose 2Experimental treatment 1 intervention
Group C: Treatment group C: HRS-1780 tablet Dose 3Experimental treatment 1 intervention
Group D: Treatment group D: HRS-1780 tablet placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in trough seated SBP at Week 12

Time frame
baseline and Week 12

Secondary outcomes

1

Change from baseline in trough seated DBP at Week 12

Time frame
baseline and Week 12
2

Change from baseline in trough seated SBP at Week 8

Time frame
baseline and Week 8
3

Proportion of participants achieving trough seated blood pressure < 140/90 mmHg at Week 12

Time frame
Week 12
4

Proportion of participants achieving trough seated SBP < 130 mmHg at Week 12

Time frame
Week 12

Other outcomes

Sponsors and contacts

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

Shandong Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: