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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05359068
• Other study ID #: SPH3127-301
• Status: Completed
• Phase: Phase 3
• Start date: June 10, 2021
• Est. completion date: December 26, 2023

Study information

• Verified date: June 2023
• Source: Shanghai Pharmaceuticals Holding Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 957
• Est. completion date: December 26, 2023
• Est. primary completion date: December 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• SPH3127 tablet
1 tablet
• SPH3127 tablet
2 tablets
• SPH3127 tablet
4 tablets
• Valsartan
1 valsartan capsule
• SPH3127 tablet
2 tablets
• Valsartan
1 valsartan capsule

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology	Baotou	Inner Mongolia
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Beijing Pinggu Hospital	Beijing	Beijing
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	XiangYa Hospital CentralSouth University	Changsha	Hunan
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Chifeng Municipal Hospital	Chifeng	Inner Mongolia
China	Affiliated Hospital of Chongqing Three Gorges Medical College	Chongqing	Chongqing
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Guangdong Second Provincial General Hospital	Guangzhou	Guangdong
China	Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Provincial people's Hospital	Hangzhou	Zhejiang
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Liuzhou people's Hospital	Liuzhou	Guangxi
China	Luoyang Third People's Hospital	Luoyang	Henan
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjin	Jiangsu
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	Hainan Third People's Hospital	Sanya	Hainan
China	Ruijin Hospital, Shanghai Jiaotong University School Of Medicine	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The People's Hospital of Liaoning Province	Shenyang	Liaoning
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Third Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Suzhou Municipal Hospital	Suzhou	Jiangsu
China	People's Hospital of Tianjin	Tianjin	Tianjin
China	Tianjin Fourth Central Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Tongji hospital,Tongji Medical college of HUST	Wuhan	Hubei
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	The First People's Hospital of Yinchuan	Yinchuan	Ningxia
China	Yuncheng Central Hospital	Yuncheng	Shanxi
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean sitting diastolic blood pressure (msDBP) at week 12		Measure at week 12 of treatment.
Secondary	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.
Secondary	Changes from baseline in mean sitting diastolic blood pressure (msSBP) at week 2, 4, 6, 8, 10 and 12.		Measured at week 2, 4, 6, 8, 10, and 12 of treatment.
Secondary	Total effective rate at week 2, 4, 6, 8, 10 and 12		Measured at week 2, 4, 6, 8, 10, and 12 of treatment.
Secondary	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.
Secondary	Number of subjects with adverse event.		12 weeks.
Secondary	Plasma concentration of SPH3127.		12 weeks.
Secondary	Relationship between SPH3127 exposure and renin inhibition level/efficacy/adverse events		12 weeks.