Menu
Recruiting NCT06523465

Statin Combined with Amlodipine Treats Primary Aldosteronism

Phase IV Interventional Primary Aldosteronism Statin Mineralocorticoid Receptor Antagonist Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Simvastatin combined with Amlodipine besylate, Simvastatin combined with Spironolactone and Amlodipine besylate., Amlodipine besylate combined Spironolactone.
Who it may be relevant to
Registry conditions: Primary Aldosteronism, Statin, Mineralocorticoid Receptor Antagonist, Hypertension. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • changes in plasma aldosterone levels [Time frame: 6 month]
  • changes in 24-hour urinary aldosterone levels [Time frame: 6 month]
Secondary outcome measures (5)
  • changes in office blood pressure and home blood pressure [Time frame: 6 month]
  • changes in serum potassium levels [Time frame: 6 month]
  • changes in serum renin level [Time frame: 6 month]
  • changes in plasma cholesterol levels [Time frame: 6 month]
  • changes in blood glucose [Time frame: 6 month]

Eligibility criteria

Inclusion criteria

  • Clinical diagnosis of primary aldosteronism

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • No. 10 Changjiang River Branch, Yuzhong District，Chongqing, China — Chongqing

Identifiers

NCT: NCT06523465 · STOP-PA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗