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

December 22, 2015 updated by: Novartis Pharmaceuticals

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
910

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos aires, Argentina, C1120AAC
        • Novartis Investigative Site
      • Cordoba, Argentina, X5003DCP
        • Novartis Investigative Site
      • Corrientes, Argentina, W3400
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1440AAD
        • Novartis Investigative Site
      • Lanus, Buenos Aires, Argentina, B8000XAV
        • Novartis Investigative Site
    • Capital Federal
      • Caba, Capital Federal, Argentina, C1179AAB
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000AII
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S200CXP
        • Novartis Investigative Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, T4000EBR
        • Novartis Investigative Site
  • Canada
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
        • Novartis Investigative Site
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Novartis Investigative Site
      • Ste-Foy, Quebec, Canada, G1V 4G2
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1045
        • Novartis Investigative Site
      • Budapest, Hungary, 1136
        • Novartis Investigative Site
      • Csongrad, Hungary, 6640
        • Novartis Investigative Site
      • Erd, Hungary, H-2030
        • Novartis Investigative Site
      • Miskolc, Hungary, 3525
        • Novartis Investigative Site
      • Miskolc, Hungary, 3530
        • Novartis Investigative Site
      • Nyiregyháza, Hungary, 4400
        • Novartis Investigative Site
      • Szeged, Hungary, H-6720
        • Novartis Investigative Site
      • Torokbalint, Hungary, 2045
        • Novartis Investigative Site
  • India
    • Andhra Pradesh
      • Vishakhapatnam, Andhra Pradesh, India, 530002
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 051
        • Novartis Investigative Site
    • Maharashtra
      • Nashik, Maharashtra, India, 422005
        • Novartis Investigative Site
      • Nashik, Maharashtra, India, 422 005
        • Novartis Investigative Site
      • Pune, Maharashtra, India, 411005
        • Novartis Investigative Site
    • Punjab
      • Ludhiana, Punjab, India, 141002
        • Novartis Investigative Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302016
        • Novartis Investigative Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Novartis Investigative Site
      • Lucknow, Uttar Pradesh, India, 226005
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 140-743
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 150-713
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 150-950
        • Novartis Investigative Site
    • Gyeonggi-do
      • Bucheon, Gyeonggi-do, Korea, Republic of, 424-717
        • Novartis Investigative Site
      • Goyang, Gyeonggi-do, Korea, Republic of, 411-706
        • Novartis Investigative Site
      • Uijeongbu-Si, Gyeonggi-do, Korea, Republic of, 480-717
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 05505
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 137-701
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 152-703
        • Novartis Investigative Site
    • Kyunggi
      • Koyang, Kyunggi, Korea, Republic of, 410-719
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 060011
        • Novartis Investigative Site
    • District 1
      • Bucharest, District 1, Romania, 011422
        • Novartis Investigative Site
      • Bucharest, District 1, Romania, 012064
        • Novartis Investigative Site
      • Bucharest, District 1, Romania
        • Novartis Investigative Site
    • District 2
      • Bucharest, District 2, Romania, 021705
        • Novartis Investigative Site
    • Jud. Bihor
      • Oradea, Jud. Bihor, Romania, 410032
        • Novartis Investigative Site
    • Jud. Dolj
      • Craiova, Jud. Dolj, Romania, 200147
        • Novartis Investigative Site
  • Slovakia
      • Bratislava, Slovakia, 831 06
        • Novartis Investigative Site
      • Liptovsky Mikulas, Slovakia, 031 01
        • Novartis Investigative Site
      • Nitra, Slovakia, 949 01
        • Novartis Investigative Site
      • Nitra, Slovakia, 94901
        • Novartis Investigative Site
      • Nove Zamky, Slovakia, 940 01
        • Novartis Investigative Site
      • Partizanske, Slovakia, 958 01
        • Novartis Investigative Site
      • Presov, Slovakia, 080 01
        • Novartis Investigative Site
      • Presov, Slovakia, 081 01
        • Novartis Investigative Site
      • Ruzomberok, Slovakia, 034 26
        • Novartis Investigative Site
      • Sala, Slovakia, 927 03
        • Novartis Investigative Site
      • Sered, Slovakia, 926 00
        • Novartis Investigative Site
      • Zvolen, Slovakia, 960 01
        • Novartis Investigative Site
    • Slovak Republic
      • Nitra, Slovak Republic, Slovakia, 949 01
        • Novartis Investigative Site
      • Presov, Slovak Republic, Slovakia, 08001
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Novartis Investigative Site
    • Andalucia
      • Granada, Andalucia, Spain, 18012
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41009
        • Novartis Investigative Site
    • Cataluña
      • Badalona, Cataluña, Spain, 08914
        • Novartis Investigative Site
      • Centelles, Cataluña, Spain, 08540
        • Novartis Investigative Site
      • Tarragona, Cataluña, Spain, 43350
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain, 03004
        • Novartis Investigative Site
      • Alzira, Comunidad Valenciana, Spain, 46600
        • Novartis Investigative Site
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15706
        • Novartis Investigative Site
  • United States
    • Florida
      • Clearwater, Florida, United States, 33756
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novartis Investigative Site
      • Chicago, Illinois, United States, 60610
        • Novartis Investigative Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Novartis Investigative Site
    • Mississippi
      • Belzoni, Mississippi, United States, 39038
        • Novartis Investigative Site
      • Jackson, Mississippi, United States, 39202
        • Novartis Investigative Site
      • Jackson, Mississippi, United States, 39209
        • Novartis Investigative Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Novartis Investigative Site
      • St. Louis, Missouri, United States, 63031
        • Novartis Investigative Site
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Novartis Investigative Site
      • Las Vegas, Nevada, United States, 89119
        • Novartis Investigative Site
    • New York
      • Buffalo, New York, United States, 14215
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Novartis Investigative Site
      • Greensboro, North Carolina, United States, 27401
        • Novartis Investigative Site
      • Greensboro, North Carolina, United States, 27408
        • Novartis Investigative Site
      • Shelby, North Carolina, United States, 28152
        • Novartis Investigative Site
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16509
        • Novartis Investigative Site
    • Texas
      • Bryan, Texas, United States, 77802
        • Novartis Investigative Site
      • Houston, Texas, United States, 77030
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VAL + AHU 400 mg
Participants 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.
Drug: Valsartan
Valsartan was supplied as tablets in blister cards in 160 mg and 320 mg strengths.
Drug: AHU377
AHU377 was supplied in tablets in blister cards in 50 mg and 100 mg strengths.
Experimental: VAL + AHU 200 mg
Participants 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.
Drug: Valsartan
Valsartan was supplied as tablets in blister cards in 160 mg and 320 mg strengths.
Drug: AHU377
AHU377 was supplied in tablets in blister cards in 50 mg and 100 mg strengths.
Experimental: VAL + AHU 100 mg
Participants 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.
Drug: Valsartan
Valsartan was supplied as tablets in blister cards in 160 mg and 320 mg strengths.
Drug: AHU377
AHU377 was supplied in tablets in blister cards in 50 mg and 100 mg strengths.
Experimental: VAL + AHU 50 mg
Participants 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.
Drug: Valsartan
Valsartan was supplied as tablets in blister cards in 160 mg and 320 mg strengths.
Drug: AHU377
AHU377 was supplied in tablets in blister cards in 50 mg and 100 mg strengths.
Experimental: VAL 320 mg
Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
Drug: Valsartan
Valsartan was supplied as tablets in blister cards in 160 mg and 320 mg strengths.
Experimental: LCZ 400 mg
Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
Drug: LCZ696
LCZ696 was supplied as tablets in blister cards in 100 mg strengths.
Experimental: Placebo
Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
Drug: Placebo
Placebo was supplied as tablets in blister cards.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time Frame: Baseline, 8 weeks
Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.
Baseline, 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Diastolic Blood Pressure (msDBP)
Time Frame: Baseline, 8 weeks
Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.
Baseline, 8 weeks
Change From Baseline in Mean 24 Hour Ambulatory SBP (maSBP) and Mean 24 Hour Ambulatory DBP (maDBP)
Time Frame: Baseline, 8 weeks
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.
Baseline, 8 weeks
Change From Baseline in Daytime maSBP and maDBP
Time Frame: Baseline, 8 weeks
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.
Baseline, 8 weeks
Change From Baseline in Nighttime maSBP and maDBP
Time Frame: Baseline and 8 weeks
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.
Baseline and 8 weeks
Change From Baseline in Mean Sitting Pulse Pressure
Time Frame: Baseline, 8 weeks
Pulse rate measurements were performed. A negative change from baseline indicates improvement.
Baseline, 8 weeks
Change From Baseline in Mean Ambulatory Pulse Pressure
Time Frame: Baseline, 8 weeks
Pulse rate measurements were performed. A negative change from baseline indicates improvement.
Baseline, 8 weeks
Change From Baseline in maSBP and maDBP in Dippers
Time Frame: Baseline, 8 weeks
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.
Baseline, 8 weeks
Change From Baseline in maSBP and maDBP in Non-dippers
Time Frame: Baseline, 8 weeks
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.
Baseline, 8 weeks
Change From Baseline in msSBP and msDBP in Participants < 65 Years of Age
Time Frame: Baseline, 8 weeks
Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.
Baseline, 8 weeks
Change From Baseline in msSBP and msDBP in Participants >= 65 Years of Age
Time Frame: Baseline, 8 weeks
Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.
Baseline, 8 weeks
Change From Baseline in maSBP and maDBP in Participants < 65 Years of Age
Time Frame: Baseline, 8 weeks
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.
Baseline, 8 weeks
Change From Baseline in maSBP and maDBP in Participants >= 65 Years of Age
Time Frame: Baseline, 8 weeks
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.
Baseline, 8 weeks
Number of Participants Who Achieved Blood Pressure Control and Blood Pressure Response
Time Frame: 8 weeks
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.
8 weeks
Number of Participants With Adverse Events, Serious Adverse Events and Death
Time Frame: 8 weeks
Adverse event monitoring was conducted throughout the study.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLCZ696A2223
  • 2010-022326-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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