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The primary objective of this study is to test the hypothesis that amlodipine plus atorvastatin given in a single tablet (Caduet), compared with amlodipine alone (Norvasc), has a stronger effect in protection of arterial structure and function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlodipine Plus Atorvastatin (Caduet) | Experimental | amlodipine plus atorvastatin in a single tablet (Caduet, Pfizer, USA) was given once daily |
|
| Amlodipine (Norvasc) | Active Comparator | amlodipine(Norvasc, Pfizer, USA) given once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amlodipine plus atorvastatin (Caduet) | Drug |
| ||
| amlodipine (Norvasc) |
| Measure | Description | Time Frame |
|---|---|---|
| flow-mediated dilation (FMD) | After 12-week maintenance treatment or at 24-week final visit. | 12-24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| pulse wave velocity (cf-PWV, ba-PWV) | After 12-week maintenance treatment or at 24-week final visit. | 12-24 weeks |
| liver function | After 6-week maintenance treatment or at 24-week final visit. Intolerable adverse events which may or may not be related to the trial treatment, including:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Yang | Contact | 64370045 | 661124 | jesuisyang@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Institute of Hypertension | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Pingjin Gao |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D000069059 | Atorvastatin |
| C487936 | amlodipine, atorvastatin drug combination |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
| 6-24weeks |
| ankle-brachial index (ABI) | After 12-week maintenance treatment or at 24-week final visit. | 12-24 weeks |
| augmentation index (AIx) | After 12-week maintenance treatment or at 24-week final visit. | 12-24 weeks |
| carotid intima-media thickness (IMT) | After 12-week maintenance treatment or at 24-week final visit. | 12-24 weeks |
| cholesterol level | After 12-week maintenance treatment or at 24-week final visit. | 12-24 weeks |
| D011758 |
| Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |