CompletedPhase 4

Azelnidipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients by Serial Volumetric IVUS Analysis(ALPS-J)

Japan199 participantsStarted 2005-12

Plain-language summary

In patients with hypertension who undergo elective PCI, the effects of long-term administration of Calblock (azelnidipine) on plaque volume will be determined quantitatively by 3D-IVUS and compared with those of amlodipine besilate (Norvasc or Amlodin).

Who can participate

Age range

20 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: Between 20 and 79 years (at the time of giving informed consent). * Sex: Either sex. * Admission status: Outpatients. * Patients requiring treatment for hypertension according to the JSH 2004 hypertension therapy guidelines before beginning this study * Patients who have not used any calcium antagonists for at least 4 weeks before the beginning of this study. * Patients who are scheduled to undergo elective PCI. Exclusion Criteria: * Patients with acute coronary syndrome (ACS). * Patients who have experienced Q-wave myocardial infarction within 4 weeks before beginning this study. * Patients with renal dysfunction (serum creatinine \>2.0 mg/dL). * Patients in whom PCI is unsuccessful. * Patients with cardiogenic shock. * Patients with moderate or severe congestive heart failure. * Patients with 50% or more stenosis of the main trunk of the left coronary artery. * Patients with other problems whom the investigator considers unsuitable for this study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent change in plaque volume from the baseline value. (IVUS) Percent change in plaque volume = (plaque volume after 48 weeks of drug administration - baseline plaque volume) / baseline plaque volume

Timeframe: 48Weeks

Trial details

NCT IDNCT00294567

SponsorJuntendo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-05

View on ClinicalTrials.gov More Hypertension trials

Who can participate

Age range

20 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.