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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

NCT ID: NCT01281306

Last Updated: 2016-01-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

910 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Systolic Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

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

AHU377

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

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

AHU377

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

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

AHU377

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

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

AHU377

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

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

Placebo

Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo was supplied as tablets in blister cards.

Interventions

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LCZ696

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

Intervention Type DRUG

Valsartan

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

Intervention Type DRUG

AHU377

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

Intervention Type DRUG

Placebo

Placebo was supplied as tablets in blister cards.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Clearwater, Florida, United States

Site Status

Novartis Investigative Site

Chicago, Illinois, United States

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Novartis Investigative Site

Chicago, Illinois, United States

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Novartis Investigative Site

Metairie, Louisiana, United States

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Novartis Investigative Site

Belzoni, Mississippi, United States

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Novartis Investigative Site

Jackson, Mississippi, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Henderson, Nevada, United States

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Novartis Investigative Site

Las Vegas, Nevada, United States

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Novartis Investigative Site

Buffalo, New York, United States

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Novartis Investigative Site

Charlotte, North Carolina, United States

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Novartis Investigative Site

Greensboro, North Carolina, United States

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Greensboro, North Carolina, United States

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Novartis Investigative Site

Shelby, North Carolina, United States

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Novartis Investigative Site

Erie, Pennsylvania, United States

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Bryan, Texas, United States

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Houston, Texas, United States

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Buenos Aires, Buenos Aires, Argentina

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Caba, Buenos Aires, Argentina

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Lanús, Buenos Aires, Argentina

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Caba, Buenos Aires F.D., Argentina

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Corrientes, Corrientes Province, Argentina

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Córdoba, Córdoba Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Mount Pearl, Newfoundland and Labrador, Canada

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Mirabel, Quebec, Canada

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Ste-Foy, Quebec, Canada

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Csongrád, Hungary, Hungary

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Érd, Hungary, Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Miskolc, , Hungary

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Miskolc, , Hungary

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Nyiregyháza, , Hungary

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Szeged, , Hungary

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Törökbálint, , Hungary

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Visakhapatnam, Andhra Pradesh, India

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Ahmedabad, Gujarat, India

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Nashik, Maharashtra, India

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Nashik, Maharashtra, India

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Pune, Maharashtra, India

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Ludhiana, Punjab, India

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Jaipur, Rajasthan, India

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Lucknow, Uttar Pradesh, India

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Lucknow, Uttar Pradesh, India

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Bucharest, District 1, Romania

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Novartis Investigative Site

Bucharest, District 1, Romania

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Novartis Investigative Site

Bucharest, District 1, Romania

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Novartis Investigative Site

Bucharest, District 2, Romania

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Oradea, Jud. Bihor, Romania

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Craiova, Jud. Dolj, Romania

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Bucharest, , Romania

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Novartis Investigative Site

Nitra, Slovak Republic, Slovakia

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Prešov, Slovak Republic, Slovakia

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Bratislava, Slovakia, Slovakia

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Liptovský Mikuláš, Slovakia, Slovakia

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Novartis Investigative Site

Nitra, Slovakia, Slovakia

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Nitra, Slovakia, Slovakia

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Novartis Investigative Site

Nové Zámky, Slovakia, Slovakia

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Partizánske, Slovakia, Slovakia

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Prešov, Slovakia, Slovakia

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Prešov, Slovakia, Slovakia

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Ružomberok, Slovakia, Slovakia

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Sereď, Slovakia, Slovakia

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Šaľa, Slovakia, Slovakia

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Zvolen, Slovakia, Slovakia

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Bucheon-si, Gyeonggi-do, South Korea

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Goyang-si, Gyeonggi-do, South Korea

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Uijeongbu-si, Gyeonggi-do, South Korea

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Koyang, Kyunggi, South Korea

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Seoul, Seoul, South Korea

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Seoul, Seoul, South Korea

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Seoul, , South Korea

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Novartis Investigative Site

Granada, Andalusia, Spain

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Novartis Investigative Site

Seville, Andalusia, Spain

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Novartis Investigative Site

Badalona, Catalonia, Spain

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Novartis Investigative Site

Centelles, Catalonia, Spain

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Novartis Investigative Site

Tarragona, Catalonia, Spain

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Novartis Investigative Site

Santiago de Compostela, Galicia, Spain

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Novartis Investigative Site

Madrid, Madrid, Spain

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Novartis Investigative Site

Alicante, Valencia, Spain

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Novartis Investigative Site

Alzira, Valencia, Spain

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Novartis Investigative Site

Barcelona, , Spain

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Countries

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United States Argentina Canada Hungary India Romania Slovakia South Korea Spain

Other Identifiers

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2010-022326-32

Identifier Type: -

Identifier Source: secondary_id

CLCZ696A2223

Identifier Type: -

Identifier Source: org_study_id

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