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Systolic HypertensionPhase 2NCT01281306

An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension

A Phase 2 study testing LCZ696, Valsartan and AHU377 in people with Systolic Hypertension, run by Novartis Pharmaceuticals at 90 sites in 9 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

The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systolic 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
910 participants
Where
90 sitesin 9 countries
Study dates
Jan 2011to Dec 2011
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent must be obtained before any assessment is performed. Patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy.
  • Ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the run-in period.

Who cannot join

  • Severe hypertension
  • History of angioedema, drug-related or otherwise, as reported by the patient.
  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential (WOCBP), UNLESS they are using adequate birth control methods.
  • History or evidence of a secondary form of hypertension.
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

90 sites in 9 countries.

90 sites in 9 countries

United States19 sites

  • Novartis Investigative Site

    Belzoni, Mississippi, 39038

  • Novartis Investigative Site

    Bryan, Texas, 77802

  • Novartis Investigative Site

    Buffalo, New York, 14215

  • Novartis Investigative Site

    Charlotte, North Carolina, 28277

  • Novartis Investigative Site

    Chicago, Illinois, 60607

  • Novartis Investigative Site

    Chicago, Illinois, 60610

  • Novartis Investigative Site

    Clearwater, Florida, 33756

  • Novartis Investigative Site

    Erie, Pennsylvania, 16509

  • Novartis Investigative Site

    Greensboro, North Carolina, 27401

  • Novartis Investigative Site

    Greensboro, North Carolina, 27408

  • Novartis Investigative Site

    Henderson, Nevada, 89014

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Jackson, Mississippi, 39202

  • Novartis Investigative Site

    Jackson, Mississippi, 39209

  • Novartis Investigative Site

    Las Vegas, Nevada, 89119

  • Novartis Investigative Site

    Metairie, Louisiana, 70006

  • Novartis Investigative Site

    Shelby, North Carolina, 28152

  • Novartis Investigative Site

    St Louis, Missouri, 63031

  • Novartis Investigative Site

    St Louis, Missouri, 63141

Other trials in United States

Slovakia14 sites

  • Novartis Investigative Site

    Bratislava, Slovakia, 831 06

  • Novartis Investigative Site

    Liptovský Mikuláš, Slovakia, 031 01

  • Novartis Investigative Site

    Nitra, Slovak Republic, 949 01

  • Novartis Investigative Site

    Nitra, Slovakia, 949 01

  • Novartis Investigative Site

    Nitra, Slovakia, 94901

  • Novartis Investigative Site

    Nové Zámky, Slovakia, 940 01

  • Novartis Investigative Site

    Partizánske, Slovakia, 958 01

  • Novartis Investigative Site

    Prešov, Slovak Republic, 08001

  • Novartis Investigative Site

    Prešov, Slovakia, 080 01

  • Novartis Investigative Site

    Prešov, Slovakia, 081 01

  • Novartis Investigative Site

    Ružomberok, Slovakia, 034 26

  • Novartis Investigative Site

    Šaľa, Slovakia, 927 03

  • Novartis Investigative Site

    Sereď, Slovakia, 926 00

  • Novartis Investigative Site

    Zvolen, Slovakia, 960 01

Other trials in Slovakia

South Korea10 sites

  • Novartis Investigative Site

    Bucheon-si, Gyeonggi-do, 424-717

  • Novartis Investigative Site

    Goyang-si, Gyeonggi-do, 411-706

  • Novartis Investigative Site

    Koyang, Kyunggi, 410-719

  • Novartis Investigative Site

    Seoul, Korea, 05505

  • Novartis Investigative Site

    Seoul, Korea, 137-701

  • Novartis Investigative Site

    Seoul, Korea, 152-703

  • Novartis Investigative Site

    Seoul, Seoul, 140-743

  • Novartis Investigative Site

    Seoul, Seoul, 150-713

  • Novartis Investigative Site

    Seoul, 150-950

  • Novartis Investigative Site

    Uijeongbu-si, Gyeonggi-do, 480-717

Other trials in South Korea

Spain10 sites

  • Novartis Investigative Site

    Alicante, Valencia, 03004

  • Novartis Investigative Site

    Alzira, Valencia, 46600

  • Novartis Investigative Site

    Badalona, Catalonia, 08914

  • Novartis Investigative Site

    Barcelona

  • Novartis Investigative Site

    Centelles, Catalonia, 08540

  • Novartis Investigative Site

    Granada, Andalusia, 18012

  • Novartis Investigative Site

    Madrid, Madrid, 28046

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Tarragona, Catalonia, 43350

Other trials in Spain

Argentina9 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1120AAC

  • Novartis Investigative Site

    Caba, Buenos Aires, C1440AAD

  • Novartis Investigative Site

    Caba, Buenos Aires F.D., C1179AAB

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5003DCP

  • Novartis Investigative Site

    Corrientes, Corrientes Province, W3400

  • Novartis Investigative Site

    Lanus, Buenos Aires, B8000XAV

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000AII

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S200CXP

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000EBR

Other trials in Argentina

Hungary9 sites

  • Novartis Investigative Site

    Budapest, 1045

  • Novartis Investigative Site

    Budapest, 1136

  • Novartis Investigative Site

    Csongrád, Hungary, 6640

  • Novartis Investigative Site

    Érd, Hungary, H-2030

  • Novartis Investigative Site

    Miskolc, 3525

  • Novartis Investigative Site

    Miskolc, 3530

  • Novartis Investigative Site

    Nyiregyháza, 4400

  • Novartis Investigative Site

    Szeged, H-6720

  • Novartis Investigative Site

    Törökbálint, 2045

Other trials in Hungary

India9 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 051

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302016

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226003

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226005

  • Novartis Investigative Site

    Ludhiana, Punjab, 141002

  • Novartis Investigative Site

    Nashik, Maharashtra, 422 005

  • Novartis Investigative Site

    Nashik, Maharashtra, 422005

  • Novartis Investigative Site

    Pune, Maharashtra, 411005

  • Novartis Investigative Site

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Romania7 sites

  • Novartis Investigative Site

    Bucharest, District 1, 011422

  • Novartis Investigative Site

    Bucharest, District 1, 012064

  • Novartis Investigative Site

    Bucharest, District 1

  • Novartis Investigative Site

    Bucharest, District 2, 021705

  • Novartis Investigative Site

    Bucharest, 060011

  • Novartis Investigative Site

    Craiova, Jud. Dolj, 200147

  • Novartis Investigative Site

    Oradea, Jud. Bihor, 410032

Other trials in Romania

Canada3 sites

  • Novartis Investigative Site

    Mirabel, Quebec, J7J 2K8

  • Novartis Investigative Site

    Mount Pearl, Newfoundland and Labrador, A1N 1W7

  • Novartis Investigative Site

    Ste-Foy, Quebec, G1V 4G2

Other trials in Canada

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg After 8 Week Treatment in Patients With Mild-to-moderate Systolic Hypertension

The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).

Being tested
LCZ696, Valsartan, AHU377, Placebo
Keywords
hypertension, blood pressure, LCZ696, dual-acting, neprilysin, nep inhibitor, vasopeptidase, angiotensin receptor, angiotensin receptor neprilysin inhibitor (ARNi)
Medical subject headings
Isolated Systolic Hypertension, Hypertension

What participants receive

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

  • LCZ696Drug

    LCZ696 was supplied as tablets in blister cards in 100 mg strengths.

  • ValsartanDrug

    Valsartan was supplied as tablets in blister cards in 160 mg and 320 mg strengths.

  • AHU377Drug

    AHU377 was supplied in tablets in blister cards in 50 mg and 100 mg strengths.

  • PlaceboDrug

    Placebo was supplied as tablets in blister cards.

Study groups in NCT01281306
Study groupRoleWhat they receive
VAL + AHU 400 mgExperimentalParticipants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
Receives: Drug: Valsartan; Drug: AHU377
VAL + AHU 200 mgExperimentalParticipants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
Receives: Drug: Valsartan; Drug: AHU377
VAL + AHU 100 mgExperimentalParticipants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
Receives: Drug: Valsartan; Drug: AHU377
VAL + AHU 50 mgExperimentalParticipants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
Receives: Drug: Valsartan; Drug: AHU377
VAL 320 mgExperimentalParticipants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
Receives: Drug: Valsartan
LCZ 400 mgExperimentalParticipants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
Receives: Drug: LCZ696
PlaceboExperimentalParticipants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

    Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.

    Measured: Baseline, 8 weeks

Secondary outcomes (14)

  1. Change From Baseline in Mean Diastolic Blood Pressure (msDBP)

    Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.

    Measured: Baseline, 8 weeks

  2. Change From Baseline in Mean 24 Hour Ambulatory SBP (maSBP) and Mean 24 Hour Ambulatory DBP (maDBP)

    Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.

    Measured: Baseline, 8 weeks

  3. Change From Baseline in Daytime maSBP and maDBP

    Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.

    Measured: Baseline, 8 weeks

  4. Change From Baseline in Nighttime maSBP and maDBP

    Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.

    Measured: Baseline and 8 weeks

  5. Change From Baseline in Mean Sitting Pulse Pressure

    Pulse rate measurements were performed. A negative change from baseline indicates improvement.

    Measured: Baseline, 8 weeks

  6. Change From Baseline in Mean Ambulatory Pulse Pressure

    Pulse rate measurements were performed. A negative change from baseline indicates improvement.

    Measured: Baseline, 8 weeks

  7. Change From Baseline in maSBP and maDBP in Dippers

    Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.

    Measured: Baseline, 8 weeks

  8. Change From Baseline in maSBP and maDBP in Non-dippers

    Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.

    Measured: Baseline, 8 weeks

  9. Change From Baseline in msSBP and msDBP in Participants < 65 Years of Age

    Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.

    Measured: Baseline, 8 weeks

  10. Change From Baseline in msSBP and msDBP in Participants >= 65 Years of Age

    Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.

    Measured: Baseline, 8 weeks

  11. Change From Baseline in maSBP and maDBP in Participants < 65 Years of Age

    Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.

    Measured: Baseline, 8 weeks

  12. Change From Baseline in maSBP and maDBP in Participants >= 65 Years of Age

    Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.

    Measured: Baseline, 8 weeks

  13. Number of Participants Who Achieved Blood Pressure Control and Blood Pressure Response

    Sitting BP measurements were performed at trough (23-26 hours post-morning dose). Blood pressure control was defined as msSBP/MSDBP < 140/90 mmHg. Blood pressure response in msSBP was defined as <140 mmHg or a reduction >= 20mmHg from baseline. Blood pressure response in msDBP was defined as < 90 mmHg or a reduction >= 10 mmHg from baseline.

    Measured: 8 weeks

  14. Number of Participants With Adverse Events, Serious Adverse Events and Death

    Adverse event monitoring was conducted throughout the study.

    Measured: 8 weeks

Timeline

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

  1. First posted21 Jan 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

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
910 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01281306
Sponsor's protocol ID
CLCZ696A2223
Other IDs
2010-022326-32
Status last verified
Dec 2015
First submitted
20 Jan 2011
Last updated
29 Jan 2016

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LCZ696, Valsartan and AHU377 in people with Systolic Hypertension, run by Novartis Pharmaceuticals at 90 sites in 9 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 2 inclusion and 6 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 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Slovakia, South Korea, Spain, Argentina and 4 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. 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 18 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 Systolic Blood Pressure (msSBP) (time frame: Baseline, 8 weeks). 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 NCT01281306.

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 29 Jan 2016.

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