Not Yet RecruitingPhase 3

QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension

China810 participantsStarted 2024-12-30

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. History of angioedema, drug-related or otherwise.
✕. Suffered by severe cerebrovascular disease within 1 year prior to screening.
✕. Suffered by severe heart disease within 1 year prior to screening
✕. History of severe or malignant retinopathy.

What they're measuring

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

Timeframe: Baseline and week 8

Trial details

NCT IDNCT06716970

SponsorWuhan Createrna Science and Technology Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-30

Contact for this trial

Wuhan Createrna Science and Technology Co.,Ltd

+86 027-68788900 lcyxzx@createrna.com

View on ClinicalTrials.gov More Essential Hypertension trials