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A study comparing the antihypertensives Valsartan and Lisinporil when doses are in the morning and comparing a morning dose of Valsartan with an evening dose.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan | Drug | |||
| lisinopril | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Average 24 hour blood pressure less than 130/80 mmHg after 26 weeks | ||
| Change from baseline in systolic 24 hour blood pressure after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline manual blood pressure and pulse pressure after 26 weeks | ||
| Change from baseline markers of endothelial function, fibrosis, and other blood measurements of hypertension after 12 and 26 weeks |
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Inclusion Criteria:
- Hypertension defined by a MSSBP >=150 mmHg (untreated patients) or patients on current anti-hypertensive treatment who remain uncontrolled (i.e. MSSBP >140 mmHg)
Controlled type II Diabetes mellitus Hypercholesteremia, currently treated with lipid-lowering drugs Metabolic syndrome MI, CABG or PTCA more than one year ago Stroke or transient ischemic cerebral attack more than one year ago Documented history of peripheral vascular disease, increased IMT, or carotid plaques Documented history of LVH Elderly >65 years
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Centers | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25259546 | Derived | Zappe DH, Crikelair N, Kandra A, Palatini P. Time of administration important? Morning versus evening dosing of valsartan. J Hypertens. 2015 Feb;33(2):385-92. doi: 10.1097/HJH.0000000000000397. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D017706 | Lisinopril |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Changes in ambulatory blood pressure measurements at various timepoints up to 26 weeks |
| Change from baseline heart size after 26 weeks |
| Adverse events, serious adverse events, laboratory values, physical examinations, vital signs for up to 26 weeks |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |