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Completed

NCT Number: NCT05359068

Study to Evaluate the Efficacy and Safety of SPH3127 In Patients With Mild-moderate Essential Hypertension

The primary aim of the study is to assess the antihypertensive efficacy of SPH3127 in patients with mild to moderate essential hypertension.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female of age ≥18 years;
  • Diagnosed with mild-moderate essential hypertension;
  • Participant has understood the study-required procedures, voluntarily signed informed consent.

Exclusion criteria

  • Diagnosed with secondary hypertension, suspected grade 3 hypertension, acute hypertension, or at risk when current antihypertensive therapy discontinued;
  • Suffered by severe heart disease within 6 months;
  • Suffered by severe cerebrovascular disease within 6 months;
  • Suffered by severe or malignant retinopathy;
  • Out of controlled diabetes;
  • History of malignant tumor;
  • History of mental disorder;
  • Subject is planning or in use of other antihypertensive drugs or other drugs may affect blood pressure during the trial;
  • Alcohol or drug abuse;
  • Pregnant, lactating women or subject is planning to pregnant within 6 months after the trial;
  • Assessed by the investigators as unsuitable for participating in the study.

Treatment and study plan

SPH3127 tablet

Drug

1 tablet

valsartan

Drug

1 valsartan capsule

Primary outcomes

  1. Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12

    Time frame: Measure at week 12 of treatment.

Secondary outcomes

  1. Changes from baseline in mean sitting diastolic blood pressure (msDBP) at week 2, 4, 6, 8 and 10

    Time frame: Measured at week 2, 4, 6, 8 and 10 of treatment.

  2. Changes from baseline in mean sitting diastolic blood pressure (msSBP) at week 2, 4, 6, 8, 10 and 12.

    Time frame: Measured at week 2, 4, 6, 8, 10, and 12 of treatment.

  3. Total effective rate at week 2, 4, 6, 8, 10 and 12

    Time frame: Measured at week 2, 4, 6, 8, 10, and 12 of treatment.

  4. Rate of reaching target blood pressure at week 2, 4, 6, 8, 10 and 12

    Time frame: Measured at week 2, 4, 6, 8, 10, and 12 of treatment.

  5. Number of subjects with adverse event.

    Time frame: 12 weeks.

  6. Plasma concentration of SPH3127.

    Time frame: 12 weeks.

  7. Relationship between SPH3127 exposure and renin inhibition level/efficacy/adverse events

    Time frame: 12 weeks.

Sponsors and collaborators

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Double-Dummy, Positive Parallel Controlled Study to Evaluate the Efficacy and Safety in Treatment of Mild-moderate Essential Hypertension

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 3, 2022
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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