HypertensionPhase 4NCT00294567
Azelnidipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients by Serial Volumetric IVUS Analysis(ALPS-J)
A Phase 4 study testing Calcium channel blockers (amlodipine, azelnidipine) in people with Hypertension and Coronary Atherosclerosis, run by Juntendo University at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Hypertension, Coronary Atherosclerosis
- What is being tested?
- Calcium channel blockers (amlodipine, azelnidipine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2005to Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Cardiology, Juntendo University School of Medicine
Tokyo
About this study
Official title: 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)
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).
Read the detailed description
Clinical studies have demonstrated that calcium antagonists can reduce cardiovascular events in patients with coronary artery disease. Recently, suppression of the development of coronary atherosclerotic plaque by calcium antagonists has been reported as one of the mechanisms involved. Thus, calcium antagonists have been promising strategy for preventing the progression of the coronary atherosclerosis. Various calcium antagonists are clinically available at present and these drugs may differ from each other with respect to the anti-atherosclerotic effects. Consequently, we plan to perform the ALPS-J study to compare the effects of two long-acting calcium antagonists, azelnidipine and amlodipine, on plaque quantitatively by IVUS. In this study, azelnidipine (16 mg/day) or amlodipine besilate (5 mg/day) will be administered to patients with hypertension for 48 weeks after elective PCI. The plaque volume will be measured in each patient by IVUS at the time of PCI and 48 weeks after PCI. Percent change in plaque volume from the baseline value will be used as the primary endpoints for evaluation of efficacy. We plan to enroll 100 patients in each group for a total of 200 patients.
- Conditions
- Hypertension, Coronary Atherosclerosis
- Being tested
- Calcium channel blockers (amlodipine, azelnidipine)
- Keywords
- Hypertension, PCI, Calcium Channel Blockers, IVUS, Plaque
- Medical subject headings
- Hypertension, Coronary Artery Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium channel blockers (amlodipine, azelnidipine)Drug
Drug: amlodipine Drug: azelnidipine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Amlodipine Receives: Drug: Calcium channel blockers (amlodipine, azelnidipine) |
| 2 | Active comparator | Azelnidipine Receives: Drug: Calcium channel blockers (amlodipine, azelnidipine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48Weeks
Secondary outcomes (3)
Change of plaque volume from the baseline value. (IVUS) Amount change and percent change in Minimal lumen diameter and % stenosis. (Quantitative Coronary Analysis) Change of intimal thickening volume in-stent.
Measured: 48Weeks
Correlativity of plaque volume and inflammatory laboratory parameters (hs-CRP, MCP-1, PTX-3) Correlativity of laboratory parameters and blood pressure. Correlativity of plaque volume and antioxidant laboratory parameters (LPO, 8-isoprostane)
Measured: 48Weeks
The following treatments and incidence of events, Changes from baseline of laboratory parameters (TC, LDL-C,TG, HDL-C, hs-CRP, MCP-1, LPO, 8-isoprostane, PTX-3) after 48 weeks of drug administration. Correlativity of plaque volume and blood pressure.
Measured: 48Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startDec 2005
- Primary completionMay 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juntendo University
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Heart Foundation
- Responsible party
- Sponsor
- Investigators
- HIROYUKI MD DAIDA, Study chair, Director of Cardiology Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294567
- Sponsor's protocol ID
- JHF-17NOV2005
- Status last verified
- Oct 2008
- First submitted
- 20 Feb 2006
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Miyauchi K, Daida H. [Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo Medical University]. Nihon Naika Gakkai Zasshi. 2012 Oct 10;101(10):3002-11. doi: 10.2169/naika.101.3002. No abstract available. Japanese.
PubMed 23214115Kojima T, Miyauchi K, Yokoyama T, Yokoyama K, Kurata T, Suwa S, Kawamura M, Tamura H, Okazaki S, Inoue K, Fujiwara Y, Sumiyoshi M, Tanimoto K, Nakazato Y, Yamagami S, Hiro T, Komiyama N, Daida H. Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo University (ALPS-J). Circ J. 2011;75(5):1071-9. doi: 10.1253/circj.cj-11-0141. Epub 2011 Apr 7.
PubMed 21471671
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00294567
- Acronym / sponsor ID
- JHF-17NOV2005
- Conditions
- Hypertension, Coronary Atherosclerosis
- Keywords
- Hypertension, PCI, Calcium Channel Blockers, IVUS, Plaque
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Juntendo UniversityUniversity, hospital or other
- Collaborators
- Japan Heart Foundation
- Study start
- Dec 2005
- Primary completion
- May 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 22 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Clinical studies have demonstrated that calcium antagonists can reduce cardiovascular events in patients with coronary artery disease. Recently, suppression of the development of coronary atherosclerotic plaque by calcium antagonists has been reported as one of the mechanisms involved. Thus, calcium antagonists have been promising strategy for preventing the progression of the coronary atherosclerosis. Various calcium antagonists are clinically available at present and these drugs may differ from each other with respect to the anti-atherosclerotic effects. Consequently, we plan to perform the ALPS-J study to compare the effects of two long-acting calcium antagonists, azelnidipine and amlodipine, on plaque quantitatively by IVUS. In this study, azelnidipine (16 mg/day) or amlodipine besilate (5 mg/day) will be administered to patients with hypertension for 48 weeks after elective PCI. The plaque volume will be measured in each patient by IVUS at the time of PCI and 48 weeks after PCI. Percent change in plaque volume from the baseline value will be used as the primary endpoints for evaluation of efficacy. We plan to enroll 100 patients in each group for a total of 200 patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Calcium channel blockers (amlodipine, azelnidipine)Amlodipine |
| 2 | Active comparator | Drug: Calcium channel blockers (amlodipine, azelnidipine)Azelnidipine |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium channel blockers (amlodipine, azelnidipine)Drug: amlodipine Drug: azelnidipine | Drug | 1, 2 |
Primary outcome
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
3 secondary outcomes
Change of plaque volume from the baseline value. (IVUS) Amount change and percent change in Minimal lumen diameter and % stenosis. (Quantitative Coronary Analysis) Change of intimal thickening volume in-stent.
Time frame: 48Weeks
Correlativity of plaque volume and inflammatory laboratory parameters (hs-CRP, MCP-1, PTX-3) Correlativity of laboratory parameters and blood pressure. Correlativity of plaque volume and antioxidant laboratory parameters (LPO, 8-isoprostane)
Time frame: 48Weeks
The following treatments and incidence of events, Changes from baseline of laboratory parameters (TC, LDL-C,TG, HDL-C, hs-CRP, MCP-1, LPO, 8-isoprostane, PTX-3) after 48 weeks of drug administration. Correlativity of plaque volume and blood pressure.
Time frame: 48Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Derived from this study: PubMed 23214115Miyauchi K, Daida H. [Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo Medical University]. Nihon Naika Gakkai Zasshi. 2012 Oct 10;101(10):3002-11. doi: 10.2169/naika.101.3002. No abstract available. Japanese.
- Derived from this study: PubMed 21471671Kojima T, Miyauchi K, Yokoyama T, Yokoyama K, Kurata T, Suwa S, Kawamura M, Tamura H, Okazaki S, Inoue K, Fujiwara Y, Sumiyoshi M, Tanimoto K, Nakazato Y, Yamagami S, Hiro T, Komiyama N, Daida H. Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo University (ALPS-J). Circ J. 2011;75(5):1071-9. doi: 10.1253/circj.cj-11-0141. Epub 2011 Apr 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HIROYUKI MD DAIDA study chair
Director of Cardiology Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium channel blockers (amlodipine, azelnidipine) in people with Hypertension and Coronary Atherosclerosis, run by Juntendo University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00294567, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.