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This study will assess the efficacy and safety of LFF269 compared to placebo after treatment in subjects with essential hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LFF269 low dose | Experimental | LFF269 low dose + Matching Placebo to Eplerenone 50mg during 4 week double blind period |
|
| LFF269 high dose | Experimental | LFF269 high dose + Matching Placebo to Eplerenone 50mg |
|
| Eplerenone | Active Comparator | Eplerenone 50mg twice daily + matching placebo of LFF269 |
|
| Placebo | Placebo Comparator | Placebo of LFF269 high dose + Placebo of Eplerenone 50 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LFF269 | Drug |
| ||
| Eplerenone |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean 24-hour systolic blood pressure (SBP) as measured by ambulatory blood pressure monitoring (ABPM) after 4 weeks treatment | Baseline, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean 24-hour diastolic blood pressure (DBP) as measured by ABPM after 4 weeks of treatment | Baseline, week 4 | |
| Change from baseline in mean 24-hour SBP and DBP as measured by ABPM after 4 weeks treatment | Baseline, week 4 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Clinical Research Institute-Phase I | Anaheim | California | 92801 | United States | ||
| Comprehensive Phase I |
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| Label | URL |
|---|---|
| Results for CLFF269X2201 from the Novartis Clinical Trials website | View source |
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|
| Placebo | Drug |
|
| Percentage of patients experiencing adverse events during the study as measure of safety and tolerability | Adverse events will be reported as percentage of patients with total adverse events, serious adverse events and death. | 4 weeks |
| Change from baseline in mean sitting SBP and DBP after 4 weeks treatment | Baseline, week 4 |
| Percentage of patients achieving a successful BP response (> placebo) and BP control (SBP < 140 mmHg at trough) | 4 weeks |
| change from baseline in mean daytime and mean nighttime SBP and DBP as measured by ABPM after 4 weeks treatment | Baseline, week 4 |
| Pharmacokinetics of LFF269: Plasma concentrations of LFF269 | pre dose & 6 hours post study drug dose |
| Fort Myers |
| Florida |
| 333901 |
| United States |
| Comprehensive Phase OneĀ®, | Miramar | Florida | 33025 | United States |
| Comprehensive NeuroScience | St. Petersburg | Florida | 33716 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Clinical Research Advantage/ Prairie Fields Family Medicine, PC | Fremont | Nebraska | 68025 | United States |
| Internal Medicine Physicians | Omaha | Nebraska | 68130 | United States |
| ICON Developmental Solutions | Omaha | Nebraska | 68154 | United States |
| Clinical Research Advantage/ Aloha Medical | Las Vegas | Nevada | 89183 | United States |
| ICON Development Solutions, | San Antonio | Texas | 78209 | United States |
| Comprehensive Clinical Development NW, Inc. | Tacoma | Washington | 98418 | United States |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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