HypertensionPhase 2NCT00549770

Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

A Phase 2 study testing LCZ696, Valsartan and AHU377 in people with Hypertension, run by Novartis Pharmaceuticals at 182 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hypertension
What is being tested?: LCZ696, Valsartan and AHU377
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,334 participants
Where: 182 sitesin 18 countries
Study dates: Sep 2007to Jul 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or females from 18 up to and including 75 years
Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs; therapy with a fixed dose combination of two active substances represents 2 drugs)
Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2).
Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP> 95 mmHg at baseline (Visit 3);

Who cannot join

Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg)
History of angioedema, drug-related or otherwise, as reported by the patient
Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)
History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc.
History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease

Trial locations and contacts

182 sites in 18 countries.

Country

City, postcode or hospital

182 sites in 18 countries

United States38 sites

Novartis Investigative Site
Augusta, Georgia, 30904
Novartis Investigative Site
Baton Rouge, Louisiana, 70809
Novartis Investigative Site
Birmingham, Alabama, 35294-2041
Novartis Investigative Site
Brooklyn Center, Minnesota, 55430-2168
Novartis Investigative Site
Buena Park, California, 90620
Novartis Investigative Site
Chandler, Arizona, 85224
Novartis Investigative Site
Charleston, West Virginia, 25301
Novartis Investigative Site
Chelsea, Michigan, 48118
Novartis Investigative Site
Chicago, Illinois, 60607
Novartis Investigative Site
Chicago, Illinois, 60610
Novartis Investigative Site
Cincinnati, Ohio, 45219
Novartis Investigative Site
Cincinnati, Ohio, 45224
Novartis Investigative Site
City of Saint Peters, Missouri, 63376
Novartis Investigative Site
Dallas, Texas, 75235
Novartis Investigative Site
Fair Oaks, California, 95628
Novartis Investigative Site
Houston, Texas, 77030-3411
Novartis Investigative Site
Houston, Texas, 77081
Novartis Investigative Site
Houston, Texas, 77083
Novartis Investigative Site
Jacksonville, Florida, 32216
Novartis Investigative Site
Lake Jackson, Texas, 77566
Novartis Investigative Site
Long Beach, California, 90806
Novartis Investigative Site
Los Angeles, California, 90057
Novartis Investigative Site
Metairie, Louisiana, 70006
Novartis Investigative Site
Muscle Shoals, Alabama, 35662
Novartis Investigative Site
Oklahoma City, Oklahoma, 73132-4904
Novartis Investigative Site
Orangevale, California, 95662
Novartis Investigative Site
Pembroke Pines, Florida, 33024
Novartis Investigative Site
Pembroke Pines, Florida, 33029
Novartis Investigative Site
Pensacola, Florida, 32504
Novartis Investigative Site
Peoria, Illinois, 61615
Novartis Investigative Site
Richmond, Virginia, 23294
Novartis Investigative Site
Royal Oak, Michigan, 48073
Novartis Investigative Site
Santa Ana, California, 92701
Novartis Investigative Site
Simpsonville, South Carolina, 29681
Novartis Investigative Site
Stockton, California, 95204
Novartis Investigative Site
Toms River, New Jersey, 08753
Novartis Investigative Site
Trenton, New Jersey, 08629
Novartis Investigative Site
Tustin, California, 92780

Other trials in United States

Germany18 sites

Novartis Investigative Site
Balve, 58802
Novartis Investigative Site
Beckingen, 66701
Novartis Investigative Site
Berlin, 10719
Novartis Investigative Site
Berlin, 13053
Novartis Investigative Site
Einbeck, 37574
Novartis Investigative Site
Erfurt, 99084
Novartis Investigative Site
Giengen an der Brenz, 89537
Novartis Investigative Site
Hagen, 58095
Novartis Investigative Site
Haigerloch, 72401
Novartis Investigative Site
Hamburg, 22335
Novartis Investigative Site
Kassel, 34125
Novartis Investigative Site
Krefeld, 47798
Novartis Investigative Site
Mahlberg, 77972
Novartis Investigative Site
Messkirch, 88605
Novartis Investigative Site
Reinfeld, 23858
Novartis Investigative Site
Siegen, 57074
Novartis Investigative Site
Wallerfing, 94574
Novartis Investigative Site
Warendorf, 48231

Other trials in Germany

Spain18 sites

Novartis Investigative Site
Alicante, Valencia, 03004
Novartis Investigative Site
Badalona, Catalonia, 08914
Novartis Investigative Site
Barcelona, Catalonia, 08025
Novartis Investigative Site
Barcelona, Catalonia, 08905
Novartis Investigative Site
Barcelona, 08820
Novartis Investigative Site
Begonte, Galicia, 27373
Novartis Investigative Site
Benidorm, Valencia, 03550
Novartis Investigative Site
Hospitalet de Llbregat, 08902
Novartis Investigative Site
Madrid, Madrid, 28046
Novartis Investigative Site
Palma de Mallorca, Balearic Islands, 07007
Novartis Investigative Site
Petrel, 03610
Novartis Investigative Site
Quart de Poblet, Valencia, 46930
Novartis Investigative Site
Riudecols, 43390
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Seville, Andalusia, 41009
Novartis Investigative Site
Tàrrega, Catalonia, 25300
Novartis Investigative Site
Valencia, Valencia, 460009
Novartis Investigative Site
Vic, Catalonia, 08500

Other trials in Spain

Italy17 sites

Novartis Investigative Site
Caserta, CE, 81100
Novartis Investigative Site
Casorate Primo, PV, 27022
Novartis Investigative Site
Cona, FE, 44100
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Mercato San Severino, SA, 84085
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Palermo, PA, 90127
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Pisa, PI, 56124
Novartis Investigative Site
Pisa, PI, 56126
Novartis Investigative Site
Pozzilli, IS, 86077
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
San Daniele del Friuli, UD, 33038
Novartis Investigative Site
Sassari, SS, 07100
Novartis Investigative Site
Stradella, PV, 27049
Novartis Investigative Site
Vibo Valentia, VV, 89900
Novartis Investigative Site
Vimercate, MI, 20059

Other trials in Italy

Canada9 sites

Novartis Investigative Site
Cambridge, Ontario, N1R 6V6
Novartis Investigative Site
Granby, Quebec, J2G 8Z9
Novartis Investigative Site
Longueil, Quebec, J4N 1L6
Novartis Investigative Site
Mississauga, Ontario, M4T 4J2
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
Novartis Investigative Site
Saskatoon, Saskatchewan, S7H 5M3
Novartis Investigative Site
Sherbrooke, Quebec, J1J 2G2
Novartis Investigative Site
Ste-Foy, Quebec, G1V 4G2
Novartis Investigative Site
Toronto, Ontario, M9W 4L6

Other trials in Canada

Netherlands9 sites

Novartis Investigative Site
's-Hertogenbosch, 5216 GC
Novartis Investigative Site
Deurne, 5751 XJ
Novartis Investigative Site
Ermelo, 3851 EX
Novartis Investigative Site
Hoogwoud, 1718 BG
Novartis Investigative Site
Leeuwarden, 8934 AD
Novartis Investigative Site
Losser, 7581 BV
Novartis Investigative Site
Oude Pekela, 9665 AR
Novartis Investigative Site
Poortvliet, 4693 BT
Novartis Investigative Site
Wamel, 6659 BX

Other trials in Netherlands

Russia9 sites

Novartis Investigative Site
Moscow, 101990
Novartis Investigative Site
Moscow, 105077
Novartis Investigative Site
Moscow, 121552
Novartis Investigative Site
S.-Petersburg, 191187
Novartis Investigative Site
S.-Petersburg, 196247
Novartis Investigative Site
Saint Petersburg, 194044
Novartis Investigative Site
Saint Petersburg, 195067
Novartis Investigative Site
Saint Petersburg, 197022
Novartis Investigative Site
Saint Petersburg, 197341

Other trials in Russia

France8 sites

Novartis Investigative Site
Bourges, 18000
Novartis Investigative Site
La Chapelle-sur-Erdre, 44240
Novartis Investigative Site
La Roche-sur-Yon, 85000
Novartis Investigative Site
Le Pradet, 83220
Novartis Investigative Site
Murs Erigné, 49610
Novartis Investigative Site
Saint-Avertin, 37550
Novartis Investigative Site
Tours, 37000
Novartis Investigative Site
Vihiers, 49310

Other trials in France

Denmark7 sites

Novartis Investigative Site
Aalborg, DK-9000
Novartis Investigative Site
Aalborg SV, 9200
Novartis Investigative Site
Espergærde, 3060
Novartis Investigative Site
Greve, 2670
Novartis Investigative Site
Roslev, 7870
Novartis Investigative Site
Vaerloese, DK-3500
Novartis Investigative Site
Viborg, 8800

Other trials in Denmark

Sweden7 sites

Novartis Investigative Site
Arvidsjaur, 933 83
Novartis Investigative Site
Boden, Sweden, SE 961 31
Novartis Investigative Site
Karlstad, 652 25
Novartis Investigative Site
Kil, 665 30
Novartis Investigative Site
Kristianstad, 291 54
Novartis Investigative Site
Lund, SE-222 21
Novartis Investigative Site
Skellefteå, Sweden, SE 931 32

Other trials in Sweden

Taiwan7 sites

Novartis Investigative Site
Changhua, 500
Novartis Investigative Site
Taichung, Taiwan ROC, 40201
Novartis Investigative Site
Taichung County
Novartis Investigative Site
Tainan, Taiwan ROC
Novartis Investigative Site
Taipei, Taiwan, 10449
Novartis Investigative Site
Taipei, Taiwan, 114
Novartis Investigative Site
Taipei, 112

Other trials in Taiwan

Finland6 sites

Novartis Investigative Site
Helsinki, 00180
Novartis Investigative Site
Helsinki, 00350
Novartis Investigative Site
Helsinki, 00810
Novartis Investigative Site
Kerava, 04200
Novartis Investigative Site
Oulu, 90100
Novartis Investigative Site
Tampere, 33100

Other trials in Finland

Latvia6 sites

Novartis Investigative Site
Daugavplis, LV-5417
Novartis Investigative Site
Kuldīga, LV-3300
Novartis Investigative Site
Ogre, 5001
Novartis Investigative Site
Riga, 1002
Novartis Investigative Site
Riga, LV-1001
Novartis Investigative Site
Riga, LV-1012

Other trials in Latvia

Slovakia6 sites

Novartis Investigative Site
Banská Bystrica, Slovak Republic, 974 05
Novartis Investigative Site
Bratislava, Slovak Republic, 813 69
Novartis Investigative Site
Dunajská Streda, 929 01
Novartis Investigative Site
Nitra, Slovak Republic, 949 01
Novartis Investigative Site
Prešov, Slovak Republic, 080 01
Novartis Investigative Site
Žilina, 012 07

Other trials in Slovakia

Argentina5 sites

Novartis Investigative Site
Caba, Buenos Aires, C1408INH
Novartis Investigative Site
Caba, Buenos Aires, C1416DRJ
Novartis Investigative Site
Caba, Buenos Aires, C1425AST
Novartis Investigative Site
Corrientes, Corrientes Province, W3400
Novartis Investigative Site
Rosario, Santa Fe Province, S2000CXH

Other trials in Argentina

Lithuania5 sites

Novartis Investigative Site
Alytus, LT-62381
Novartis Investigative Site
Kaunas, 3007
Novartis Investigative Site
Kaunas, LT-47144
Novartis Investigative Site
Kaunas, LT-49387
Novartis Investigative Site
Klaipėda, LT-92288

Other trials in Lithuania

Hungary4 sites

Novartis Investigative Site
Budapest, 1134
Novartis Investigative Site
Esztergom, 2500
Novartis Investigative Site
Miskolc, 3526
Novartis Investigative Site
Nyiregyháza, 4400

Other trials in Hungary

Poland3 sites

Novartis Investigative Site
Oława, 55-200
Novartis Investigative Site
Ostrów Wielkopolski, 63-400
Novartis Investigative Site
Tarnów, 33-100

Other trials in Poland

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Range Study to Evaluate the Efficacy and Safety of LCZ696 Comparatively to Valsartan, and to Evaluate AHU377 to Placebo After 8 Week Treatment in Patients With Essential Hypertension

Conditions: Hypertension
Being tested: LCZ696, Valsartan, AHU377, Placebo
Keywords: Hypertension, valsartan, LCZ696
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LCZ696Drug
ValsartanDrug
AHU377Drug
PlaceboDrug

Study groups in NCT00549770
Study group	Role	What they receive
LCZ696 100 mg	Experimental	Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. Receives: Drug: LCZ696; Drug: Placebo
LCZ696 200 mg	Experimental	Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. Receives: Drug: LCZ696; Drug: Placebo
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. Receives: Drug: LCZ696; Drug: Placebo
Valsartan 80 mg	Active comparator	Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. Receives: Drug: Valsartan; Drug: Placebo
Valsartan 160 mg	Active comparator	Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsatan and AHU377 (5 tablets and 2 capsules) daily. Receives: Drug: Valsartan; Drug: Placebo
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. Receives: Drug: Valsartan; Drug: Placebo
AHU377 200 mg	Experimental	Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. Receives: Drug: AHU377; Drug: Placebo
Placebo	Placebo comparator	Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline, week 8

Secondary outcomes (8)

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.
Measured: baseline, week 8
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Percentage of Participants Who Achieved Successful Control in msDBP
Successful control in msDBP is defined as msDBP <90 mmHg.
Measured: 8 weeks
Percentage of Participants Who Achieved Successful Control in msSBP
Successful control in msSBP is defined as <140 mmHg.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Jul 2008

First posted26 Oct 2007 (estimated)
Study startSep 2007
Primary completionJul 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,334 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00549770
Sponsor's protocol ID: CLCZ696A2201
Status last verified: Aug 2015
First submitted: 5 Oct 2007
Last updated: 25 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26280447
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.
PubMed 20236700

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Range Study to Evaluate the Efficacy and Safety of LCZ696 Comparatively to Valsartan, and to Evaluate AHU377 to Placebo After 8 Week Treatment in Patients With Essential Hypertension
ClinicalTrials.gov ID: NCT00549770
Acronym / sponsor ID: CLCZ696A2201
Conditions: Hypertension
Keywords: Hypertension, valsartan, LCZ696
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,334 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 26 Oct 2007 (estimated)
Results: Posted 10 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
LCZ696 100 mg	Experimental	Drug: LCZ696, Drug: PlaceboParticipants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
LCZ696 200 mg	Experimental	Drug: LCZ696, Drug: PlaceboParticipants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
LCZ696 400 mg	Experimental	Drug: LCZ696, Drug: PlaceboParticipants 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	Drug: Valsartan, Drug: PlaceboParticipants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
Valsartan 160 mg	Active comparator	Drug: Valsartan, Drug: PlaceboParticipants received Valsartan 160 mg and matching placebo to LCZ696, Valsatan and AHU377 (5 tablets and 2 capsules) daily.
Valsartan 320 mg	Active comparator	Drug: Valsartan, Drug: PlaceboParticipants 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	Drug: AHU377, Drug: PlaceboParticipants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
Placebo	Placebo comparator	Drug: PlaceboParticipants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or females from 18 up to and including 75 years
Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs; therapy with a fixed dose combination of two active substances represents 2 drugs)
Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2).
Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP> 95 mmHg at baseline (Visit 3);

Key exclusion criteria (5 listed)

Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg)
History of angioedema, drug-related or otherwise, as reported by the patient
Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)
History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc.
History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LCZ696	Drug	LCZ696 100 mg, LCZ696 200 mg, LCZ696 400 mg
Valsartan	Drug	Valsartan 160 mg, Valsartan 320 mg, Valsartan 80 mg
AHU377	Drug	AHU377 200 mg
Placebo	Drug	AHU377 200 mg, LCZ696 100 mg, LCZ696 200 mg, LCZ696 400 mg, Placebo, Valsartan 160 mg, Valsartan 320 mg, Valsartan 80 mg

Primary outcome

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: baseline, week 8
Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.

8 secondary outcomes

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: baseline, week 8
Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP
Time frame: baseline, 8 weeks
Change From Baseline in Daytime maDBP and maSBP
Time frame: baseline, 8 weeks
Change From Baseline in Nighttime maDBP and maSBP
Time frame: baseline, 8 weeks
Percentage of Participants Who Achieved a Successful Response in msDBP
Time frame: 8 weeks
Percentage of Participants Who Achieved a Successful Response in msSBP
Time frame: 8 weeks
Percentage of Participants Who Achieved Successful Control in msDBP
Time frame: 8 weeks
Percentage of Participants Who Achieved Successful Control in msSBP
Time frame: 8 weeks

Results and safety

Results posted to the registry on 10 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LCZ696 100 mg	156	149
LCZ696 200 mg	169	158
LCZ696 400 mg	172	162
Valsartan 80 mg	163	147
Valsartan 160 mg	166	149
Valsartan 320 mg	164	151
AHU377 200 mg	165	151
Placebo	173	148

Primary outcome: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

Time frame: baseline, week 8. Least squares mean (Standard Error). Unit: mmHg

Measure	LCZ696 100 mg n = 154	LCZ696 200 mg n = 168	LCZ696 400 mg n = 170	Valsartan 80 mg n = 163	Valsartan 160 mg n = 163	Valsartan 320 mg n = 163	AHU377 200 mg n = 164	Placebo n = 172
Value	-9.97 (0.73)	-12.92 (0.70)	-13.63 (0.70)	-9.14 (0.72)	-9.95 (0.71)	-10.93 (0.71)	-9.76 (0.71)	-6.78 (0.69)

Population analysed: 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.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LCZ696 100 mg	1 of 156 (0.6%)	4 of 156 (2.6%)	Not reported
LCZ696 200 mg	0 of 169 (0%)	4 of 169 (2.4%)	Not reported
LCZ696 400 mg	1 of 172 (0.6%)	4 of 172 (2.3%)	Not reported
Valsartan 80 mg	1 of 163 (0.6%)	5 of 163 (3.1%)	Not reported
Valsartan 160 mg	0 of 166 (0%)	4 of 166 (2.4%)	Not reported
Valsartan 320 mg	0 of 164 (0%)	3 of 164 (1.8%)	Not reported
AHU377 200 mg	0 of 165 (0%)	5 of 165 (3%)	Not reported
Placebo	0 of 173 (0%)	13 of 173 (7.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26280447Andersen 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.
Derived from this study: PubMed 20236700Ruilope 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.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

Novartis Pharmaceuticals study chair

Novartis Pharmaceuticals

182 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LCZ696, Valsartan and AHU377 in people with Hypertension, run by Novartis Pharmaceuticals at 182 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in United States, Germany, Spain, Italy, Canada and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) (time frame: baseline, week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00549770, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.