Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCZ696 100 mg | Experimental | Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
| LCZ696 200 mg | Experimental | Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
| LCZ696 400 mg | Experimental | Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
| Valsartan 80 mg | Active Comparator | Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
| Valsartan 160 mg | Active Comparator | Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsatan and AHU377 (5 tablets and 2 capsules) daily. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCZ696 | Drug |
| ||
| Valsartan |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement. | baseline, week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | Sitting BP measurements were performed at screening through the end of the study at every study visit. | baseline, week 8 |
| Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35294-2041 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26280447 | Derived | Andersen MB, Simonsen U, Wehland M, Pietsch J, Grimm D. LCZ696 (Valsartan/Sacubitril)--A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):14-22. doi: 10.1111/bcpt.12453. Epub 2015 Sep 4. | |
| 20236700 | Derived | Ruilope LM, Dukat A, Bohm M, Lacourciere Y, Gong J, Lefkowitz MP. Blood-pressure reduction with LCZ696, a novel dual-acting inhibitor of the angiotensin II receptor and neprilysin: a randomised, double-blind, placebo-controlled, active comparator study. Lancet. 2010 Apr 10;375(9722):1255-66. doi: 10.1016/S0140-6736(09)61966-8. Epub 2010 Mar 16. |
Not provided
Not provided
After successful completion of the pre-randomization period, participants were randomized 1:1:1:1:1:1:1:1 ratio to one of 8 treatment groups.
The study comprised 3 periods: a 4-week washout and placebo run-in period (pre-randomization), an 8-week randomized, double-blind monotherapy period, and 1-week randomized, placebo-controlled withdrawal period. In the randomized withdrawal, participants were either randomized to placebo or continued their original assigned treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LCZ696 100 mg | Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| FG001 | LCZ696 200 mg | Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Valsartan 320 mg | Active Comparator | Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
| AHU377 200 mg | Experimental | Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. |
|
| Placebo | Placebo Comparator | Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
| Drug |
|
| AHU377 | Drug |
|
| Placebo | Drug |
|
Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. |
| baseline, 8 weeks |
| Change From Baseline in Daytime maDBP and maSBP | Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the avergae of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm. | baseline, 8 weeks |
| Change From Baseline in Nighttime maDBP and maSBP | Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am. | baseline, 8 weeks |
| Percentage of Participants Who Achieved a Successful Response in msDBP | Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline. | 8 weeks |
| Percentage of Participants Who Achieved a Successful Response in msSBP | Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline. | 8 weeks |
| Percentage of Participants Who Achieved Successful Control in msDBP | Successful control in msDBP is defined as msDBP <90 mmHg. | 8 weeks |
| Percentage of Participants Who Achieved Successful Control in msSBP | Successful control in msSBP is defined as <140 mmHg. | 8 weeks |
| Muscle Shoals |
| Alabama |
| 35662 |
| United States |
| Novartis Investigative Site | Chandler | Arizona | 85224 | United States |
| Novartis Investigative Site | Buena Park | California | 90620 | United States |
| Novartis Investigative Site | Fair Oaks | California | 95628 | United States |
| Novartis Investigative Site | Long Beach | California | 90806 | United States |
| Novartis Investigative Site | Los Angeles | California | 90057 | United States |
| Novartis Investigative Site | Orangevale | California | 95662 | United States |
| Novartis Investigative Site | Santa Ana | California | 92701 | United States |
| Novartis Investigative Site | Stockton | California | 95204 | United States |
| Novartis Investigative Site | Tustin | California | 92780 | United States |
| Novartis Investigative Site | Jacksonville | Florida | 32216 | United States |
| Novartis Investigative Site | Pembroke Pines | Florida | 33024 | United States |
| Novartis Investigative Site | Pembroke Pines | Florida | 33029 | United States |
| Novartis Investigative Site | Pensacola | Florida | 32504 | United States |
| Novartis Investigative Site | Augusta | Georgia | 30904 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60607 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60610 | United States |
| Novartis Investigative Site | Peoria | Illinois | 61615 | United States |
| Novartis Investigative Site | Baton Rouge | Louisiana | 70809 | United States |
| Novartis Investigative Site | Metairie | Louisiana | 70006 | United States |
| Novartis Investigative Site | Chelsea | Michigan | 48118 | United States |
| Novartis Investigative Site | Royal Oak | Michigan | 48073 | United States |
| Novartis Investigative Site | Brooklyn Center | Minnesota | 55430-2168 | United States |
| Novartis Investigative Site | City of Saint Peters | Missouri | 63376 | United States |
| Novartis Investigative Site | Toms River | New Jersey | 08753 | United States |
| Novartis Investigative Site | Trenton | New Jersey | 08629 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45219 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45224 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73132-4904 | United States |
| Novartis Investigative Site | Simpsonville | South Carolina | 29681 | United States |
| Novartis Investigative Site | Dallas | Texas | 75235 | United States |
| Novartis Investigative Site | Houston | Texas | 77030-3411 | United States |
| Novartis Investigative Site | Houston | Texas | 77081 | United States |
| Novartis Investigative Site | Houston | Texas | 77083 | United States |
| Novartis Investigative Site | Lake Jackson | Texas | 77566 | United States |
| Novartis Investigative Site | Richmond | Virginia | 23294 | United States |
| Novartis Investigative Site | Charleston | West Virginia | 25301 | United States |
| Novartis Investigative Site | Caba | Buenos Aires | C1408INH | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1416DRJ | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1425AST | Argentina |
| Novartis Investigative Site | Corrientes | Corrientes Province | W3400 | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000CXH | Argentina |
| Novartis Investigative Site | Cambridge | Ontario | N1R 6V6 | Canada |
| Novartis Investigative Site | Mississauga | Ontario | M4T 4J2 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M9W 4L6 | Canada |
| Novartis Investigative Site | Granby | Quebec | J2G 8Z9 | Canada |
| Novartis Investigative Site | Longueil | Quebec | J4N 1L6 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H1T 2M4 | Canada |
| Novartis Investigative Site | Sherbrooke | Quebec | J1J 2G2 | Canada |
| Novartis Investigative Site | Ste-Foy | Quebec | G1V 4G2 | Canada |
| Novartis Investigative Site | Saskatoon | Saskatchewan | S7H 5M3 | Canada |
| Novartis Investigative Site | Aalborg | DK-9000 | Denmark |
| Novartis Investigative Site | Aalborg SV | 9200 | Denmark |
| Novartis Investigative Site | Espergærde | 3060 | Denmark |
| Novartis Investigative Site | Greve | 2670 | Denmark |
| Novartis Investigative Site | Roslev | 7870 | Denmark |
| Novartis Investigative Site | Vaerloese | DK-3500 | Denmark |
| Novartis Investigative Site | Viborg | 8800 | Denmark |
| Novartis Investigative Site | Helsinki | 00180 | Finland |
| Novartis Investigative Site | Helsinki | 00350 | Finland |
| Novartis Investigative Site | Helsinki | 00810 | Finland |
| Novartis Investigative Site | Kerava | 04200 | Finland |
| Novartis Investigative Site | Oulu | 90100 | Finland |
| Novartis Investigative Site | Tampere | 33100 | Finland |
| Novartis Investigative Site | Bourges | 18000 | France |
| Novartis Investigative Site | La Chapelle-sur-Erdre | 44240 | France |
| Novartis Investigative Site | La Roche-sur-Yon | 85000 | France |
| Novartis Investigative Site | Le Pradet | 83220 | France |
| Novartis Investigative Site | Murs Erigné | 49610 | France |
| Novartis Investigative Site | Saint-Avertin | 37550 | France |
| Novartis Investigative Site | Tours | 37000 | France |
| Novartis Investigative Site | Vihiers | 49310 | France |
| Novartis Investigative Site | Balve | 58802 | Germany |
| Novartis Investigative Site | Beckingen | 66701 | Germany |
| Novartis Investigative Site | Berlin | 10719 | Germany |
| Novartis Investigative Site | Berlin | 13053 | Germany |
| Novartis Investigative Site | Einbeck | 37574 | Germany |
| Novartis Investigative Site | Erfurt | 99084 | Germany |
| Novartis Investigative Site | Giengen an der Brenz | 89537 | Germany |
| Novartis Investigative Site | Hagen | 58095 | Germany |
| Novartis Investigative Site | Haigerloch | 72401 | Germany |
| Novartis Investigative Site | Hamburg | 22335 | Germany |
| Novartis Investigative Site | Kassel | 34125 | Germany |
| Novartis Investigative Site | Krefeld | 47798 | Germany |
| Novartis Investigative Site | Mahlberg | 77972 | Germany |
| Novartis Investigative Site | Messkirch | 88605 | Germany |
| Novartis Investigative Site | Reinfeld | 23858 | Germany |
| Novartis Investigative Site | Siegen | 57074 | Germany |
| Novartis Investigative Site | Wallerfing | 94574 | Germany |
| Novartis Investigative Site | Warendorf | 48231 | Germany |
| Novartis Investigative Site | Budapest | 1134 | Hungary |
| Novartis Investigative Site | Esztergom | 2500 | Hungary |
| Novartis Investigative Site | Miskolc | 3526 | Hungary |
| Novartis Investigative Site | Nyiregyháza | 4400 | Hungary |
| Novartis Investigative Site | Caserta | CE | 81100 | Italy |
| Novartis Investigative Site | Cona | FE | 44100 | Italy |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Pozzilli | IS | 86077 | Italy |
| Novartis Investigative Site | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Vimercate | MI | 20059 | Italy |
| Novartis Investigative Site | Palermo | PA | 90127 | Italy |
| Novartis Investigative Site | Padova | PD | 35128 | Italy |
| Novartis Investigative Site | Pisa | PI | 56124 | Italy |
| Novartis Investigative Site | Pisa | PI | 56126 | Italy |
| Novartis Investigative Site | Casorate Primo | PV | 27022 | Italy |
| Novartis Investigative Site | Pavia | PV | 27100 | Italy |
| Novartis Investigative Site | Stradella | PV | 27049 | Italy |
| Novartis Investigative Site | Mercato San Severino | SA | 84085 | Italy |
| Novartis Investigative Site | Sassari | SS | 07100 | Italy |
| Novartis Investigative Site | San Daniele del Friuli | UD | 33038 | Italy |
| Novartis Investigative Site | Vibo Valentia | VV | 89900 | Italy |
| Novartis Investigative Site | Daugavplis | LV-5417 | Latvia |
| Novartis Investigative Site | Kuldīga | LV-3300 | Latvia |
| Novartis Investigative Site | Ogre | 5001 | Latvia |
| Novartis Investigative Site | Riga | 1002 | Latvia |
| Novartis Investigative Site | Riga | LV-1001 | Latvia |
| Novartis Investigative Site | Riga | LV-1012 | Latvia |
| Novartis Investigative Site | Alytus | LT-62381 | Lithuania |
| Novartis Investigative Site | Kaunas | 3007 | Lithuania |
| Novartis Investigative Site | Kaunas | LT-47144 | Lithuania |
| Novartis Investigative Site | Kaunas | LT-49387 | Lithuania |
| Novartis Investigative Site | Klaipėda | LT-92288 | Lithuania |
| Novartis Investigative Site | 's-Hertogenbosch | 5216 GC | Netherlands |
| Novartis Investigative Site | Deurne | 5751 XJ | Netherlands |
| Novartis Investigative Site | Ermelo | 3851 EX | Netherlands |
| Novartis Investigative Site | Hoogwoud | 1718 BG | Netherlands |
| Novartis Investigative Site | Leeuwarden | 8934 AD | Netherlands |
| Novartis Investigative Site | Losser | 7581 BV | Netherlands |
| Novartis Investigative Site | Oude Pekela | 9665 AR | Netherlands |
| Novartis Investigative Site | Poortvliet | 4693 BT | Netherlands |
| Novartis Investigative Site | Wamel | 6659 BX | Netherlands |
| Novartis Investigative Site | Ostrów Wielkopolski | 63-400 | Poland |
| Novartis Investigative Site | Oława | 55-200 | Poland |
| Novartis Investigative Site | Tarnów | 33-100 | Poland |
| Novartis Investigative Site | Moscow | 101990 | Russia |
| Novartis Investigative Site | Moscow | 105077 | Russia |
| Novartis Investigative Site | Moscow | 121552 | Russia |
| Novartis Investigative Site | S.-Petersburg | 191187 | Russia |
| Novartis Investigative Site | S.-Petersburg | 196247 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194044 | Russia |
| Novartis Investigative Site | Saint Petersburg | 195067 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197022 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197341 | Russia |
| Novartis Investigative Site | Banská Bystrica | Slovak Republic | 974 05 | Slovakia |
| Novartis Investigative Site | Bratislava | Slovak Republic | 813 69 | Slovakia |
| Novartis Investigative Site | Nitra | Slovak Republic | 949 01 | Slovakia |
| Novartis Investigative Site | Prešov | Slovak Republic | 080 01 | Slovakia |
| Novartis Investigative Site | Dunajská Streda | 929 01 | Slovakia |
| Novartis Investigative Site | Žilina | 012 07 | Slovakia |
| Novartis Investigative Site | Seville | Andalusia | 41009 | Spain |
| Novartis Investigative Site | Palma de Mallorca | Balearic Islands | 07007 | Spain |
| Novartis Investigative Site | Badalona | Catalonia | 08914 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08025 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08905 | Spain |
| Novartis Investigative Site | Tàrrega | Catalonia | 25300 | Spain |
| Novartis Investigative Site | Vic | Catalonia | 08500 | Spain |
| Novartis Investigative Site | Begonte | Galicia | 27373 | Spain |
| Novartis Investigative Site | Santiago de Compostela | Galicia | 15706 | Spain |
| Novartis Investigative Site | Madrid | Madrid | 28046 | Spain |
| Novartis Investigative Site | Alicante | Valencia | 03004 | Spain |
| Novartis Investigative Site | Benidorm | Valencia | 03550 | Spain |
| Novartis Investigative Site | Quart de Poblet | Valencia | 46930 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 460009 | Spain |
| Novartis Investigative Site | Barcelona | 08820 | Spain |
| Novartis Investigative Site | Hospitalet de Llbregat | 08902 | Spain |
| Novartis Investigative Site | Petrel | 03610 | Spain |
| Novartis Investigative Site | Riudecols | 43390 | Spain |
| Novartis Investigative Site | Boden | Sweden | SE 961 31 | Sweden |
| Novartis Investigative Site | Skellefteå | Sweden | SE 931 32 | Sweden |
| Novartis Investigative Site | Arvidsjaur | 933 83 | Sweden |
| Novartis Investigative Site | Karlstad | 652 25 | Sweden |
| Novartis Investigative Site | Kil | 665 30 | Sweden |
| Novartis Investigative Site | Kristianstad | 291 54 | Sweden |
| Novartis Investigative Site | Lund | SE-222 21 | Sweden |
| Novartis Investigative Site | Taipei | Taiwan | 10449 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan | 114 | Taiwan |
| Novartis Investigative Site | Taichung | Taiwan ROC | 40201 | Taiwan |
| Novartis Investigative Site | Tainan | Taiwan ROC | Taiwan |
| Novartis Investigative Site | Changhua | 500 | Taiwan |
| Novartis Investigative Site | Taichung County | Taiwan |
| Novartis Investigative Site | Taipei | 112 | Taiwan |
| FG002 | LCZ696 400 mg | Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| FG003 | Valsartan 80 mg | Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| FG004 | Valsartan 160 mg | Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| FG005 | Valsartan 320 mg | Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| FG006 | AHU377 200 mg | Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. |
| FG007 | Placebo | Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| Intent-to-treat Population |
|
| Ambulatory Blood Pressure Monitoring |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LCZ696 100 mg | Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| BG001 | LCZ696 200 mg | Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| BG002 | LCZ696 400 mg | Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| BG003 | Valsartan 80 mg | Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| BG004 | Valsartan 160 mg | Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| BG005 | Valsartan 320 mg | Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| BG006 | AHU377 200 mg | Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. |
| BG007 | Placebo | Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement. | Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period. | Posted | Least Squares Mean | Standard Error | mmHg | baseline, week 8 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | Sitting BP measurements were performed at screening through the end of the study at every study visit. | Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period. | Posted | Least Squares Mean | Standard Error | mmHg | baseline, week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. | Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values. | Posted | Least Squares Mean | Standard Error | mmHg | baseline, 8 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Daytime maDBP and maSBP | Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the avergae of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm. | Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values. | Posted | Least Squares Mean | Standard Error | mmHg | baseline, 8 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Nighttime maDBP and maSBP | Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am. | Participants from the ABPM subset, who had both baseline nighttime and week 8 nighttime values, were included in the analysis only. | Posted | Least Squares Mean | Standard Error | mmHg | baseline, 8 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Successful Response in msDBP | Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline. | Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period. | Posted | Number | Percentage of participants | 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Successful Response in msSBP | Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline. | Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period. | Posted | Number | Percentage of participants | 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Successful Control in msDBP | Successful control in msDBP is defined as msDBP <90 mmHg. | Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period. | Posted | Number | Percentage of participants | 8 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Successful Control in msSBP | Successful control in msSBP is defined as <140 mmHg. | Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period. | Posted | Number | Percentage of participants | 8 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LCZ696 100 mg | Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 1 | 156 | 4 | 156 | ||
| EG001 | LCZ696 200 mg | Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 0 | 169 | 4 | 169 | ||
| EG002 | LCZ696 400 mg | Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 1 | 172 | 4 | 172 | ||
| EG003 | Valsartan 80 mg | Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 1 | 163 | 5 | 163 | ||
| EG004 | Valsartan 160 mg | Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 0 | 166 | 4 | 166 | ||
| EG005 | Valsartan 320 mg | Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 0 | 164 | 3 | 164 | ||
| EG006 | AHU377 200 mg | Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. | 0 | 165 | 5 | 165 | ||
| EG007 | Placebo | Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. | 0 | 173 | 13 | 173 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| D000068756 | Valsartan |
| C000717211 | sacubitril |
| 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 |
Not provided
Not provided
| Male |
|
Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
| OG004 | Valsartan 160 mg | Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG005 | Valsartan 320 mg | Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG006 | AHU377 200 mg | Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. |
| OG007 | Placebo | Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
|
Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG004 | Valsartan 160 mg | Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG005 | Valsartan 320 mg | Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG006 | AHU377 200 mg | Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. |
| OG007 | Placebo | Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
|
| OG003 |
| Valsartan 80 mg |
Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG004 | Valsartan 160 mg | Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG005 | Valsartan 320 mg | Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG006 | AHU377 200 mg | Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. |
| OG007 | Placebo | Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
|
| Valsartan 80 mg |
Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG004 | Valsartan 160 mg | Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG005 | Valsartan 320 mg | Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG006 | AHU377 200 mg | Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. |
| OG007 | Placebo | Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
|
Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
| OG004 | Valsartan 160 mg | Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG005 | Valsartan 320 mg | Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG006 | AHU377 200 mg | Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. |
| OG007 | Placebo | Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
|
Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
| OG004 | Valsartan 160 mg | Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG005 | Valsartan 320 mg | Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG006 | AHU377 200 mg | Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. |
| OG007 | Placebo | Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
|
| OG004 | Valsartan 160 mg | Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG005 | Valsartan 320 mg | Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG006 | AHU377 200 mg | Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. |
| OG007 | Placebo | Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
|
| OG004 | Valsartan 160 mg | Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG005 | Valsartan 320 mg | Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
| OG006 | AHU377 200 mg | Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. |
| OG007 | Placebo | Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. |
|
|