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Calcium Channel Blocker

Amlodipine for Primary Aldosteronism (CCB-PA Trial)

Phase 2
Waitlist Available
Led By Anand Vaidya, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights

CCB-PA Trial Summary

This trial is testing whether a calcium channel blocker can help people with a certain type of hypertension caused by an excess of aldosterone.

Who is the study for?
This trial is for adults with primary aldosteronism, a condition causing high blood pressure due to excess hormone production. Participants must have low plasma renin activity and be diagnosed with idiopathic bilateral hyperaldosteronism. They should be on medical therapy, not surgery, and able to switch from current calcium channel blockers or mineralocorticoid receptor antagonists if needed.Check my eligibility
What is being tested?
The study tests Amlodipine, a calcium channel blocker, as a potential targeted treatment for reducing aldosterone production in patients with specific genetic mutations associated with primary aldosteronism.See study design
What are the potential side effects?
Amlodipine may cause swelling of the legs or ankles, fatigue, stomach pain, dizziness, flushing (feeling warm), palpitations (irregular heartbeat), and in rare cases more serious heart problems.

CCB-PA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 24-hour Urinary Aldosterone Excretion Rate
Change in Plasma Aldosterone Concentration
Secondary outcome measures
Acute change in Plasma Aldosterone Concentration
Acute change in Systolic Blood pressure

Side effects data

From 2019 Phase 4 trial • 44 Patients • NCT02034435
7%
Headache
4%
numbness
4%
Dizziness/Lightheadedness
4%
viral illness
4%
Low glucose
4%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aim 1- Low Sodium
Aim 2- Amlodipine
Aim 2- Eplerenone
Aim 1- High Sodium

CCB-PA Trial Design

1Treatment groups
Experimental Treatment
Group I: AmlodipineExperimental Treatment1 Intervention
Amlodipine (dose 10 mg, once daily)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amlodipine
2004
Completed Phase 4
~40680

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,609 Previous Clinical Trials
11,470,312 Total Patients Enrolled
University of MichiganOTHER
1,795 Previous Clinical Trials
6,373,921 Total Patients Enrolled
Anand Vaidya, MDPrincipal Investigator - Brigham and Women's Hospital
Boston Children's Hospital, Dana-Farber Cancer Institute
Harvard Medical Sch (Medical School)
Brigham & Women'S Hospital (Residency)
2 Previous Clinical Trials
106 Total Patients Enrolled

Media Library

Amlodipine (Calcium Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04179019 — Phase 2
Conn Syndrome Research Study Groups: Amlodipine
Conn Syndrome Clinical Trial 2023: Amlodipine Highlights & Side Effects. Trial Name: NCT04179019 — Phase 2
Amlodipine (Calcium Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04179019 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been recruited for this research initiative?

"Affirmative. According to clinicaltrials.gov, this research is currently sourcing participants since its first posting on September 1st 2020 and last update November 26th 2021. The study requires 15 patients from a single medical centre for enrollment."

Answered by AI

Are there any specific criteria for enrolling in this research project?

"Candidates wishing to take part in the trial must suffer from adrenogenital syndrome and be between 18 and 80 years of age. In total, this medical study is enrolling 15 individuals."

Answered by AI

Are individuals younger than sixty years of age being considered for participation in this clinical study?

"This clinical trial is open to participants aged 18 and over, up to a maximum of 80 years old."

Answered by AI

In which medical conditions is Amlodipine commonly prescribed?

"Amlodipine is typically prescribed to manage cardiovascular issues, such as dyslipidemias, coronary artery disease (CAD), and high risk cardiopathy."

Answered by AI

What adverse effects might be incurred by using Amlodipine?

"Amlodipine's safety was rated a 2 out of 3, as this is still an early phase trial and there has been no conclusive data yet surrounding its efficacy."

Answered by AI

Are there currently any openings to take part in this clinical experiment?

"Clinicaltrials.gov states that this trial is still admiting participants, having been initially posted on September 1st 2020 and recently updated on November 26th 2021."

Answered by AI

Can you provide information on any past experiments that have included Amlodipine?

"Presently, 29 trials related to Amlodipine are taking place. 6 of those clinical studies have reached Phase 3 status and span across 318 medical centres with the majority being located in Boston, MA."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Calcium Channel Blockade in Primary Aldosteronism
Anand Vaidya 2020. "Calcium Channel Blockade in Primary Aldosteronism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04179019.
~3 spots leftby Apr 2025
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