NCT06500689

To Assess Allisartan Isoproxil/Sustained-Release Indapamide in Patients With Essential Hypertension Uncontrolled With Allisartan Isoproxil

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study will be to assess the efficacy and safety of Allisartan Isoproxil/sustained-release indapamide (240 mg/1.5 mg) in patients with mild to moderate essential hypertension uncontrolled after 4-week treatment with Allisartan Isoproxil (240 mg).

Detailed description

Allisartan isoproxil is a novel angiotensin receptor blocke available in China for over ten years and has the same active compound EXP3174 with losartan, while sustained-release indapamide is a long-standing thiazide-type diuretic. The novel single-pill combination of allisartan isoproxil and sustained-release indapamide exerts synergistic antihypertensive effects.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Allisartan Isoproxil/Sustained-Release Indapamide	Double-blind period (Week 1\~Week 12): Allisartan Isoproxil/Sustained-Release Indapamide. Open-label period (Week 13\~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide.
DRUG	Allisartan Isoproxil	Double-blind period (Week 1\~Week 12): Allisartan Isoproxil. Open-label period (Week 13\~Week 52): Allisartan Isoproxil/Sustained-Release Indapamide.

Timeline

• Start date: 2021-12-30
• Primary completion: 2023-11-27
• Completion: 2024-05-24
• First posted: 2024-07-15
• Last updated: 2024-07-15

Locations

40 sites across 1 country: China