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NCT00294567
Azelnidipine and Amlodipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients Undergoing Coronary Intervention by Serial Volumetric Intravascular Ultrasound Analysis in Junten Medical University (ALPS-J)
Phase 4 trial testing Calcium channel blockers (amlodipine, azelnidipine) in Hypertension in 199 participants. Completed in 1 January 2011.
1 May 2009
Quick facts
| Lead sponsor | Juntendo University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 199 |
| Start date | 1 December 2005 |
| Primary completion | 1 May 2009 |
| Estimated completion | 1 January 2011 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- Calcium channel blockers (amlodipine, azelnidipine) — full drug profile →
Conditions studied
- Hypertension — all drugs for Hypertension →
- Coronary Atherosclerosis — all drugs for Coronary Atherosclerosis →
Sponsor
Juntendo University
Who can join
Adults 20 to 79, any sex, with Hypertension or Coronary Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Time frame: 48Weeks
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00294567
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Juntendo University trials
Trials by the same sponsor.
- NCT05392764 — Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure · Phase 3 · recruiting
- NCT04950842 — Induction of Transplant Tolerance in LDLT Via iTS · Phase 1, PHASE2 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00294567 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Juntendo University
- Last refreshed: 12 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00294567.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing