QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension

December 3, 2024 updated by: Wuhan Createrna Science and Technology Co., Ltd

A Multicenter, Randomized, Double-blind, and Active-controlled Parallel Study to Evaluate the Efficacy and Safety of QR12000 Compound Tablets and Sacubitril/valsartan Tablets in Patients with Moderate to Severe Essential Hypertension

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
810

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Wuhan Createrna Science and Technology Co.,Ltd
  • Phone Number: +86 027-68788900
  • Email: lcyxzx@createrna.com

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects who can understand and are willing to complying with protocol requirement and sign the informed consent form.
  2. Man or woman aged 18 years to 75 years (inclusive), with BMI≤30 kg/m2.
  3. 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.
  4. Subjects who agree to use adequate contraception from 2 weeks prior to screening to 1 month after last dose.

Exclusion Criteria:

  1. History or evidence of a secondary form of hypertension.
  2. History of peripheral arterial occlusive disease and Raynaud's syndrome.
  3. History of hyperthyroidism.
  4. History of hypotension.
  5. History of angioedema, drug-related or otherwise.
  6. Suffered by severe cerebrovascular disease within 1 year prior to screening.
  7. Suffered by severe heart disease within 1 year prior to screening
  8. History of severe or malignant retinopathy.
  9. History of aortic aneurysm or dissection, cardiac surgery, or percutaneous coronary intervention within 1 year prior to screening.
  10. History of malignant tumor within 5 years prior to screening.
  11. Poorly controlled diabetes prior to screening
  12. History of severe autoimmune diseases.
  13. History of severe mental disorder.
  14. Clinically significant laboratory abnormalities.
  15. History of allergy to the test drug, active control drug, or drugs similar to the test drug and positive control drug or related excipients.
  16. Undergone gastrointestinal surgery that could significantly alter drug absorption, distribution, metabolism, and excretion, or with severe gastrointestinal diseases, dysphagia, or recurrent vomiting that causes difficulty in eating or taking medication.
  17. Intolerance to the run-in period.
  18. Poor medication compliance or other non-compliance during run-in period.
  19. Participated in any interventional clinical trial within 3 months prior to screening, plan to participate in another clinical trial during the period of this trial, or plan to participate in another clinical trial within 1 month after the end of this trial.
  20. History of alcohol abuse within 6 months prior to screening or evidence of drug abuse.
  21. Not agree or unable to comply with the restrictions on concomitant treatment during the study.
  22. Pregnancy test positive, lactating women, or women planning to become pregnant.
  23. High-altitude workers or large motor vehicle drivers and other professionals engaged in hazardous mechanical operations.
  24. Other conditions that by the investigator's discretion may interfere with efficacy or safety assessment of the study, or pose a great risk to the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: QR12000 75mg
Participants will be treated with one tablet of QR12000 75mg, one tablet of QR12000 150mg placebo and one tablet of Sacubitril/valsartan 200 mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Drug: QR12000 75mg
QR12000 75mg QD
Drug: QR12000 150mg placebo
Matching placebo of QR12000 150mg QD
Drug: Sacubitril/valsartan 200mg placebo
Matching placebo of Sacubitril/valsartan 200mg QD
Experimental: QR12000 150mg
Participants will be treated with one tablet of QR12000 150mg, one tablet of QR12000 75mg placebo and one tablet of Sacubitril/valsartan 200 mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Drug: Sacubitril/valsartan 200mg placebo
Matching placebo of Sacubitril/valsartan 200mg QD
Drug: QR12000 75mg placebo
Matching placebo of QR12000 75mg QD
Drug: QR12000 150mg
QR12000 150mg QD
Active Comparator: Sacubitril/valsartan 200 mg
Participants will be treated with one tablet of Sacubitril/valsartan 200 mg, one tablet of QR12000 75mg placebo and one tablet of QR12000 150mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Drug: QR12000 150mg placebo
Matching placebo of QR12000 150mg QD
Drug: QR12000 75mg placebo
Matching placebo of QR12000 75mg QD
Drug: Sacubitril/valsartan 200mg
Sacubitril/valsartan 200mg QD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time Frame: Baseline and week 8
The change in msSBP measured at Week 8 relative to baseline.
Baseline and week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Sitting Diastolic BP (msDBP)
Time Frame: Baseline and week 8
The change in msDBP measured at Week 8 relative to baseline.
Baseline and week 8
Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP)
Time Frame: Baseline and week 8
The change in maSBP/maDBP measured at Week 8 relative to baseline.
Baseline and week 8
Change From Baseline in Daytime ( > 6am and ≤ 10 pm) or Nighttime (> 10 pm and ≤ 6 am) maSBP/maDBP
Time Frame: Baseline and week 8
The change in Daytime or Nighttime maSBP/maDBP measured at Week 8 relative to baseline.
Baseline and week 8
Percentage of Participants Achieving BP Control
Time Frame: Baseline and week 8
BP control is defined as msSBP <140 mm Hg and msDBP <90 mm Hg.
Baseline and week 8
Percentage of Participants Achieving BP Response
Time Frame: Baseline and week 8
BP Response is defined as msSBP <140 mm Hg and/or a reduction of ≥20 mm Hg from Baseline and msDBP <90 mm Hg and/or a reduction of ≥10 mm Hg from Baseline.
Baseline and week 8
Change From Baseline in msSBP/msDBP
Time Frame: Baseline, week 28 and week 52
The change in msSBP/msDBP measured at Week 28 and Week 52 relative to baseline.
Baseline, week 28 and week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuhan Createrna Science and Technology Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QR12000-GXY-3-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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