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The population for this current study will include stage 1 and stage 2 hypertensive patients who are newly diagnosed or didn't have treatment during the last 3 months and patients who are currently treated but uncontrolled on present monotherapy.
The purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan | Drug | |||
| amlodipine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure less than 140/90 mmHg after 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure less than 140/90 mmHg after 4, 8, and 11 weeks | ||
| Blood pressure less than 140/90 mmHg after 4, 8, 11, and 14 weeks | ||
| Time when blood pressure reaches less than 140/90 mmHg |
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Inclusion criteria Stage/grade 1 or stage/ grade 2 hypertension, MSSBP ≥ 140 mm Hg, and/ or MSDBP ≥ 90 mm Hg, at Visit 1 and 2 in untreated patients Or Patients who are currently treated on monotherapy and uncontrolled and have a blood pressure ≤ 160/100 mm Hg at Visit 1 and Visit 2
Exclusion criteria Current treatment with a CCB MSSBP ≥ 180 mm Hg or MSDBP ≥ 110 mm Hg at any time between visit 1 and Visit 2 History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures Evidence of a secondary form of hypertension Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1 Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novatis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Centers | Germany | |||||
| Novartis Pharmaceuticals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19898644 | Result | Zappe D, Papst CC, Ferber P; PROMPT Investigators. Randomized study to compare valsartan +/- HCTZ versus amlodipine +/- HCTZ strategies to maximize blood pressure control. Vasc Health Risk Manag. 2009;5:883-92. doi: 10.2147/vhrm.s8062. Epub 2009 Nov 2. |
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| Change in blood pressure at baseline, week 4, 8, 11, and 14 |
| Adverse events and serious adverse events at each study visit for 14 weeks |
| Basel |
| Switzerland |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
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