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Statin Combined with Amlodipine Treats Primary Aldosteronism (STOP-PA)

T

Third Military Medical University

Status and phase

Enrolling
Phase 4

Conditions

Statin
Hypertension
Mineralocorticoid Receptor Antagonist
Primary Aldosteronism

Treatments

Drug: Simvastatin combined with Spironolactone and Amlodipine besylate.
Drug: Amlodipine besylate combined Spironolactone
Drug: Simvastatin combined with Amlodipine besylate

Study type

Interventional

Funder types

Other

Identifiers

NCT06523465
STOP-PA

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of primary aldosteronism

Exclusion criteria

  • Allergy to drugs in this study
  • Pregnancy
  • Severe liver and kidney dysfunction
  • Mental illness

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 3 patient groups

Simvastatin combined with Amlodipine besylate
Experimental group
Description:
after 1:1 randomization, 60 patients with primary aldosteronism were treated with Simvastatin combined with Amlodipine besylate for 6 months
Treatment:
Drug: Simvastatin combined with Amlodipine besylate
Simvastatin combined with Spironolactone and Amlodipine besylate.
Experimental group
Description:
after 1:1 randomization, 60 patients with primary aldosteronism were treated with Simvastatin combined with Spironolactone and Amlodipine besylate for 6 months
Treatment:
Drug: Simvastatin combined with Spironolactone and Amlodipine besylate.
Amlodipine besylate combined with Spironolactone
Experimental group
Description:
after 1:1 randomization, 60 patients with primary aldosteronism were treated with Amlodipine besylate combined with Spironolactone for 6 months
Treatment:
Drug: Amlodipine besylate combined Spironolactone

Trial contacts and locations

1

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Central trial contact

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Data sourced from clinicaltrials.gov

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