NCT06523465

Statin Combined with Amlodipine Treats Primary Aldosteronism

A Prospective, Multi-center, Randomized Trial to Compare Statin Combined with CCB to MRA Combined with CCB in Primary Aldosteronism Treatment

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The drug treatment for primary aldosteronism (PA) is limited and difficult to improve long-term cardiovascular outcomes. This study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: Statin combined with amlodipine besylate, scheme 2: Statin combined with Spironolactone and Amlodipine besylate. scheme 3: Amlodipine besylate combined with Spironolactone , to observe the changes in plasma aldosterone level, 24-hour urinary aldosterone, blood pressure, and long-term cardiovascular risk.

Conditions

• Primary Aldosteronism
• Statin
• Mineralocorticoid Receptor Antagonist
• Hypertension

Interventions

Type	Name	Description
DRUG	Simvastatin combined with Amlodipine besylate	6-month treatment of Simvastatin combined with Amlodipine besylate
DRUG	Simvastatin combined with Spironolactone and Amlodipine besylate.	6-month treatment of Simvastatin combined with Spironolactone and Amlodipine besylate.
DRUG	Amlodipine besylate combined Spironolactone	6-month treatment of Amlodipine besylate combined with Spironolactone

Timeline

• Start date: 2024-09-10
• Primary completion: 2025-12-30
• Completion: 2026-09-30
• First posted: 2024-07-26
• Last updated: 2024-11-22

Locations

1 site across 1 country: China