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The purpose of this study is to demonstrate the antihypertensive efficacy of once daily oral administration of ACT 280778 on DBP compared to placebo after 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | ACT-280778 |
|
| Treatment B | Placebo Comparator | Placebo |
|
| Treatment C | Other | Amlodipine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-280778 | Drug | 10 mg once daily for 28 ± 2 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean(c) trough(d) SiDBP | Change from baseline(b) to Day 28 (± 2 days) of Period 2 (Visit 7)in mean(c) trough(d) SiDBP. | Baseline to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean trough SiSBP. | Change from baseline to Day 28 (± 2 days) of Period 2 (Visit 7) in mean trough SiSBP. | Baseline to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kasra Shakeri-Nejad, MD, PhD | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigative Site 4000 | Afula | 18101 | Israel | |||
| Clinical Investigative Site 1003 |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000592016 | isobutyric acid 2-(2-((3-(4,7-dimethoxy-1H-benzoimidazol-2-yl)propyl)methylamino)ethyl)-5-phenylbicyclo(2.2.2)oct-5-en-2-yl ester |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Placebo oral capsules matching ACT-280778 |
|
| Amlodipine | Drug | 10 mg once daily for 28 ± 2 days |
|
| Ashkelon |
| 78278 |
| Israel |
| Clinical Investigative Site 1008 | Beersheba | 84101 | Israel |
| Clinical Investigative Site 1004 | Giv‘atayim | 53583 | Israel |
| Clinical Investigative Site 1009 | Holon | 58100 | Israel |
| Clinical Investigative Site 1000 | Jerusalem | 91004 | Israel |
| Clinical Investigative Site 1006 | Nazareth | 16100 | Israel |
| Clinical Investigative Site 1007 | Nazareth | 16100 | Israel |
| Clinical Investigative Site 1005 | Safed | 13100 | Israel |
| Clinical Investigative Site 1010 | Tel Aviv | 66872 | Israel |
| Clinical Investigative Site 1012 | Tel Litwinsky | 52621 | Israel |
| Clinical Investigative Site 3001 | Belgrade | 11000 | Serbia |
| Clinical InvestigativeSite 3003 | Belgrade | 11000 | Serbia |
| Clinical Investigative Site 4001 | Belgrade | 11040 | Serbia |
| Clinical Investigative Site 3004 | Belgrade | 11080 | Serbia |
| Clinical Investigative Site 3000 | Niška Banja | 18205 | Serbia |
| Clinical Investigative Site 4002 | Pančevo | 26000 | Serbia |
| Clinical Investigative Site 3002 | Zemun | 11080 | Serbia |