NCT06465264

To Assess Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine or Allisartan Isoproxil

Efficacy and Safety of Allisartan Isoproxil/Amlodipine in Patients With Essential Hypertension Uncontrolled With Amlodipine or Allisartan Isoproxil: A Phase III, Multicenter, Randomized, Double-blind, Parallel-controlled, 52-week Clinical Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 499 (actual)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study will be to assess the efficacy and safety of Allisartan Isoproxil/Amlodipine (240 mg/5 mg) in patients with mild to moderate essential hypertension uncontrolled after 4-week treatment with Amlodipine besylate（5 mg) or Allisartan Isoproxil (240 mg).

Detailed description

Amlodipine belongs to the calcium channel blocker (CCB) class of drugs, which acts as an antihypertensive agent mainly via blocking calcium channels on the vascular smooth muscle cells to dilate blood vessels. Allisartan Isoproxil belongs to the ARB class of drugs, which can effectively exert antihypertensive effects. The combination of dihydropyridine CCBs and ARBs exerts synergistic antihypertensive effects.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Allisartan Isoproxil/Amlodipine group 1	One Allisartan Isoproxil/Amlodipine (240 mg/5 mg) tablet and one placebo of Amlodipine during the double-blind period (Week 4\~Week 16). One Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16\~ Week 56) once daily.
DRUG	Amlodipine group 1	One Amlodipine (5 mg) tablet and one placebo of Allisartan Isoproxil/Amlodipine during the double-blind period (Week 4\~Week 16). One Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16\~ Week 56) once daily.
DRUG	Allisartan Isoproxil/Amlodipine group 2	One Allisartan Isoproxil/Amlodipine (240 mg/5 mg) tablet and one placebo of Allisartan Isoproxil (240 mg) during the double-blind period (Week 4\~Week 16). One Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16\~ Week 56) once daily.
DRUG	Allisartan Isoproxil group 2	One Allisartan Isoproxil (240 mg) and one placebo of Allisartan Isoproxil/Amlodipine (240 mg/5 mg) during the double-blind period (Week 4\~Week 16). One Allisartan Isoproxil/Amlodipine(240 mg/5 mg) tablet during the open-label period(Week 16\~ Week 56) once daily.

Timeline

• Start date: 2021-04-29
• Primary completion: 2022-08-16
• Completion: 2023-02-24
• First posted: 2024-06-18
• Last updated: 2024-06-28

Locations

1 site across 1 country: China