QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWuhan Createrna Science and Technology Co., Ltd

About this trial

The purpose of the study is to evaluate the efficacy and safety of QR12000 75mg, QR12000 150mg and Sacubitril/valsartan 200mg in patients with moderate to severe essential hypertension.

Eligibility criteria

Qualifiers

Subjects who can understand and are willing to complying with protocol requirement and sign the informed consent form.

Man or woman aged 18 years to 75 years (inclusive), with BMI≤30 kg/m2.

Patients with moderate to severe hypertension. Untreated patients must have an msSBP ≥ 160 mmHg and < 190 mmHg at the screening and randomization visit; Treated patients must have an msSBP≥150 mmHg and <180 mmHg or msSBP≥140 mmHg and <170 mmHg at the screening visit based on numbers of antihypertensive and msSBP≥160 mmHg <190 mmHg at the randomization visit; Patients must have an absolute difference of ≤20 mmHg in msSBP between randomization visit and the immediately preceding visit.

Subjects who agree to use adequate contraception from 2 weeks prior to screening to 1 month after last dose.

Disqualifiers

History or evidence of a secondary form of hypertension.

History of peripheral arterial occlusive disease and Raynaud's syndrome.

History of hyperthyroidism.

History of hypotension.

Trial design

Treatments tested in this trial

  • QR12000 75mg
  • QR12000 75mg placebo
  • QR12000 150mg
  • QR12000 150mg placebo
  • Sacubitril/valsartan 200mg
  • Sacubitril/valsartan 200mg placebo

Treatment groups

810 Participants
are divided into 3 treatment groups