Health TrialsbyHealthPanel

QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension

ConditionEssential 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • QR12000 75mg

    Drug

    QR12000 75mg QD

  • QR12000 75mg placebo

    Drug

    Matching placebo of QR12000 75mg QD

  • QR12000 150mg

    Drug

    QR12000 150mg QD

  • QR12000 150mg placebo

    Drug

    Matching placebo of QR12000 150mg QD

  • Sacubitril/valsartan 200mg

    Drug

    Sacubitril/valsartan 200mg QD

  • Sacubitril/valsartan 200mg placebo

    Drug

    Matching placebo of Sacubitril/valsartan 200mg QD

Treatment groups

810 Participants
are divided into 3 treatment groups
Group A: QR12000 75mgExperimental treatment 3 interventions
Group B: QR12000 150mgExperimental treatment 3 interventions
Group C: Sacubitril/valsartan 200 mgActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

The change in msSBP measured at Week 8 relative to baseline.

Time frame
Baseline and week 8

Secondary outcomes

1

Change From Baseline in Mean Sitting Diastolic BP (msDBP)

The change in msDBP measured at Week 8 relative to baseline.

Time frame
Baseline and week 8
2

Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP)

The change in maSBP/maDBP measured at Week 8 relative to baseline.

Time frame
Baseline and week 8
3

Change From Baseline in Daytime ( > 6am and ≤ 10 pm) or Nighttime (> 10 pm and ≤ 6 am) maSBP/maDBP

The change in Daytime or Nighttime maSBP/maDBP measured at Week 8 relative to baseline.

Time frame
Baseline and week 8
4

Percentage of Participants Achieving BP Control

BP control is defined as msSBP \<140 mm Hg and msDBP \<90 mm Hg.

Time frame
Baseline and week 8

Other outcomes

Sponsors and contacts

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

Wuhan Createrna Science and Technology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

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