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

Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05359068
Collaborator
(none)
900
Enrollment
14
Locations
6
Arms
34.7
Anticipated Duration (Months)
64.3
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jun 10, 2021
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stage 1 Arm A

Patients with essential hypertension, received SPH 3127 tablet 50 mg once daily for 12 weeks.

Drug: SPH3127 tablet
50 mg tablet
Experimental: Stage 1 Arm B

Patients with essential hypertension, received SPH 3127 tablet 100 mg once daily for 12 weeks.

Drug: SPH3127 tablet
100 mg tablet
Experimental: Stage 1 Arm C

Patients with essential hypertension, received SPH 3127 tablet 200 mg once daily for 12 weeks.

Drug: SPH3127 tablet
200 mg tablet
Experimental: Stage 1 Arm D

Patients with essential hypertension, received Valsartan 80 mg once daily for 12 weeks.

Drug: Valsartan
Valsartan 80mg
Experimental: Stage 2 Arm A

Patients with essential hypertension, received SPH 3127 tablet 100 mg once daily for 12 weeks.

Drug: SPH3127 tablet
100 mg tablet
Experimental: Stage 2 Arm B

Patients with essential hypertension, received Valsartan 80 mg once daily for 12 weeks.

Drug: Valsartan
Valsartan 80mg

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12 [Measure at week 12 of treatment.]

Secondary Outcome Measures

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

  2. Changes from baseline in mean sitting diastolic blood pressure (msDBP) at week 2, 4, 6, 8, 10 and 12. [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 [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 [Measured at week 2, 4, 6, 8, 10, and 12 of treatment.]

  5. Number of subjects with adverse event. [12 weeks.]

  6. Serum concentration of SPH3127. [12 weeks.]

  7. Relationship between SPH3127 exposure and renin inhibition level/efficacy/adverse events [12 weeks.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Male or female of age ≥18 years;

  2. Diagnosed with mild-moderate essential hypertension;

  3. Participant has understood the study-required procedures, voluntarily signed informed consent.

Exclusion Criteria:

  1. Diagnosed with secondary hypertension, suspected grade 3 hypertension, acute hypertension, or at risk when current antihypertensive therapy discontinued;

  2. Suffered by severe heart disease within 6 months;

  3. Suffered by severe cerebrovascular disease within 6 months;

  4. Suffered by severe or malignant retinopathy;

  5. Out of controlled diabetes;

  6. History of malignant tumor;

  7. History of mental disorder;

  8. Subject is planning or in use of other antihypertensive drugs or other drugs may affect blood pressure during the trial;

  9. Alcohol or drug abuse;

  10. Pregnant, lactating women or subject is planning to pregnant within 6 months after the trial;

  11. Assessed by the investigators as unsuitable for participating in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Hospital Beijing Beijing China 100005
2 Beijing Anzhen Hospital, Capital Medical University Beijing Beijing China 100069
3 Affiliated Hospital of Chongqing Three Gorges Medical College Chongqing Chongqing China 404037
4 Hainan Third People's Hospital Sanya Hainan China 571199
5 Cangzhou Central Hospital Cangzhou Hebei China 061011
6 The First Hospital of Hebei Medical University Shijiazhuang Hebei China 050030
7 The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology Baotou Inner Mongolia China 750306
8 The Second Affiliated Hospital of Nanjing Medical University Nanjin Jiangsu China 210003
9 Suzhou Municipal Hospital Suzhou Jiangsu China 215008
10 Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu China 210031
11 Shengjing Hospital of China Medical University Shenyang Liaoning China 110022
12 The People's Hospital of Liaoning Province Shenyang Liaoning China 110067
13 Yuncheng Central Hospital Yuncheng Shanxi China 044099
14 People's Hospital of Tianjin Tianjin Tianjin China 300122

Sponsors and Collaborators

  • Shanghai Pharmaceuticals Holding Co., Ltd

Investigators

  • Principal Investigator: Changsheng Ma, Beijing Anzhen Hospital, Capitcal Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Pharmaceuticals Holding Co., Ltd
ClinicalTrials.gov Identifier:
NCT05359068
Other Study ID Numbers:
  • SPH3127-301
First Posted:
May 3, 2022
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypertension
Essential Hypertension
Valsartan

Study Results

No Results Posted as of May 6, 2022