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
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01281306
First received: January 20, 2011
Last updated: January 27, 2013
Last verified: January 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Systolic Hypertension |
Drug: LCZ696 Drug: AHU377 Drug: Valsartan Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Valsartan
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- reduction in mean sitting systolic blood pressure (msSBP) [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- dose-response relationship in sitting diastolic blood pressure (msDBP) lowering of ascending doses of AHU377 in combination with valsartan 320 mg [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
- changes in mean 24 hour ambulatory SBP (maSBP), mean 24 hour ambulatory DBP (maDBP), daytime and nighttime msSBP/maDBP of ascending doses of AHU377 in combination with valsartan 320mg as compared to valsartan 320mg monotherapy [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
- office and ambulatory pulse pressure for all treatment groups [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
- dose-response relationship in msSBP/msDBP and maSBP/maDBP lowering of ascending doses of AHU377 in combination with valsartan 320mg by sub-group analysis of age (< 65 and ≥ 65) [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
- Frequency of adverse events, serious adverse events, and notable laboratory abnormalities [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 1301 |
| Study Start Date: | January 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: LCZ696 400 mg
patients will start with 200mg LCZ696 qd for one week, thereafter they will be up-titrated to 400 mg LCZ696 given once daily for the remaining 7 weeks
|
Drug: LCZ696
LCZ696 400 mg, LCZ696 200 mg
|
|
Experimental: AHU377 400 mg + valsartan 320 mg
patients will start with AHU377 100mg + valsartan 160 mg for one week, they will be up-titrated to AHU377 200 mg + valsartan 320 mg for one week and thereafter they will be up-titrated to AHU377 400 mg +valsartan 320 mg for the remaining 6 weeks
|
Drug: AHU377
AHU377 100 mg, AHU377 50 mg
Drug: Valsartan
Valsartan 320 mg, Valsartan 160 mg
|
|
Experimental: AHU377 200 mg + valsartan 320 mg
patients will start with AHU377 100 mg + valsartan 160 mg for one week, thereafter they will be up-titrated to AHU377 200 mg + valsartan 320 mg for the remaining 7 weeks
|
Drug: AHU377
AHU377 100 mg, AHU377 50 mg
Drug: Valsartan
Valsartan 320 mg, Valsartan 160 mg
|
|
Experimental: AHU377 100 mg + valsartan 320 mg
patient will start with AHU377 50 mg + valsartan 160 mg for one week, thereafter they will be up-titrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks
|
Drug: AHU377
AHU377 100 mg, AHU377 50 mg
Drug: Valsartan
Valsartan 320 mg, Valsartan 160 mg
|
|
Experimental: AHU377 50 mg + valsartan 320 mg
patients will start with AHU377 50 mg + valsartan 160 mg for one week, thereafter they will be up-titrated to AHU377 50 mg + valsartan 320 mg for the remaining 7 weeks
|
Drug: AHU377
AHU377 100 mg, AHU377 50 mg
Drug: Valsartan
Valsartan 320 mg, Valsartan 160 mg
|
|
Experimental: valsartan 320 mg
patients will start with valsartan 160 mg for one week, thereafter they will be up-titrated to valsartan 320 mg for the remaining 7 weeks
|
Drug: Valsartan
Valsartan 320 mg, Valsartan 160 mg
|
|
Experimental: placebo
patients will receive matching placebo for 8 weeks
|
Drug: placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 76 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281306
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| United States, Florida | |
| Novartis Investigative Site | |
| Clearwater, Florida, United States, 33756 | |
| United States, Illinois | |
| Novartis Investigative Site | |
| Chicago, Illinois, United States, 60607 | |
| Novartis Investigative Site | |
| Chicago, Illinois, United States, 60610 | |
| United States, Louisiana | |
| Novartis Investigative Site | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Mississippi | |
| Novartis Investigative Site | |
| Belzoni, Mississippi, United States, 39038 | |
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| Jackson, Mississippi, United States, 39202 | |
| Novartis Investigative Site | |
| Jackson, Mississippi, United States, 39209 | |
| United States, Missouri | |
| Novartis Investigative Site | |
| St. Louis, Missouri, United States, 63031 | |
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| St. Louis, Missouri, United States, 63141 | |
| United States, Nevada | |
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| Henderson, Nevada, United States, 89014 | |
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| Las Vegas, Nevada, United States, 89119 | |
| United States, New York | |
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| Buffalo, New York, United States, 14215 | |
| United States, North Carolina | |
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| Charlotte, North Carolina, United States, 28277 | |
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| Greensboro, North Carolina, United States, 27408 | |
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| Greensboro, North Carolina, United States, 27401 | |
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| Shelby, North Carolina, United States, 28152 | |
| United States, Pennsylvania | |
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| Erie, Pennsylvania, United States, 16509 | |
| United States, Texas | |
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| Bryan, Texas, United States, 77802 | |
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| Houston, Texas, United States, 77030 | |
| Argentina | |
| Novartis Investigative Site | |
| Rosario, Santa Fe, Argentina, S2000AII | |
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| Rosario, Santa Fe, Argentina, S2132XAC | |
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| San Miguel de Tucuman, Tucuman, Argentina, T4000EBR | |
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| Buenos Aires, Argentina, C1440AAD | |
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| Buenos aires, Argentina, C1120AAC | |
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| Buenos Aires, Argentina, B8000XAV | |
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| Capital Federal, Argentina, C1179AAB | |
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| Cordoba, Argentina, X5003DCP | |
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| Corrientes, Argentina, 3400 | |
| Canada, Newfoundland and Labrador | |
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| Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7 | |
| Canada, Quebec | |
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| Mirabel, Quebec, Canada, J7J 2K8 | |
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| Ste-Foy, Quebec, Canada, G1V 4G2 | |
| Hungary | |
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| Budapest, Hungary, 1136 | |
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| Budapest, Hungary, 1045 | |
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| Csongrad, Hungary, 6640 | |
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| Erd, Hungary, H-2030 | |
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| Miskolc, Hungary, 3530 | |
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| Miskolc, Hungary, 3525 | |
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| Nyiregyháza, Hungary, 4400 | |
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| Szeged, Hungary, H-6720 | |
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| Torokbalint, Hungary, 2045 | |
| India | |
| Novartis Investigative Site | |
| Vishakhapatnam, Andhra Pradesh, India, 530002 | |
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| Ahmedabad, Gujarat, India, 380 051 | |
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| Nashik, Maharashtra, India, 422005 | |
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| Nashik, Maharashtra, India, 422 005 | |
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| Pune, Maharashtra, India, 411005 | |
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| Ludhiana, Punjab, India, 141002 | |
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| Jaipur, Rajasthan, India, 302016 | |
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| Lucknow, Uttar Pradesh, India, 226005 | |
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| Lucknow, Uttar Pradesh, India, 226003 | |
| Korea, Republic of | |
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| Bucheon, Gyeonggi-do, Korea, Republic of, 424-717 | |
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| Goyang, Gyeonggi-do, Korea, Republic of, 411-706 | |
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| Uijeongbu-Si, Gyeonggi-do, Korea, Republic of, 480-717 | |
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| Koyang, Kyunggi, Korea, Republic of, 410-719 | |
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| Seoul, Korea, Republic of, 738-736 | |
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| Seoul, Korea, Republic of, 137-701 | |
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| Seoul, Korea, Republic of, 152-703 | |
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| Seoul, Korea, Republic of, 150-950 | |
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| Seoul, Korea, Republic of, 150-713 | |
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| Seoul, Korea, Republic of, 140-743 | |
| Romania | |
| Novartis Investigative Site | |
| Bucharest, District 1, Romania | |
| Novartis Investigative Site | |
| Bucharest, District 1, Romania, 012064 | |
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| Bucharest, District 1, Romania, 011422 | |
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| Bucharest, District 2, Romania, 021705 | |
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| Bucuresti, District 2, Romania, 021345 | |
| Novartis Investigative Site | |
| Oradea, Jud. Bihor, Romania, 410032 | |
| Novartis Investigative Site | |
| Craiova, Jud. Dolj, Romania, 200147 | |
| Novartis Investigative Site | |
| Bucharest, Romania, 060011 | |
| Slovakia | |
| Novartis Investigative Site | |
| Nitra, Slovak Republic, Slovakia, 949 01 | |
| Novartis Investigative Site | |
| Presov, Slovak Republic, Slovakia, 08001 | |
| Novartis Investigative Site | |
| Bratislava, Slovakia, 831 06 | |
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| Liptovsky Mikulas, Slovakia, 031 01 | |
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| Nitra, Slovakia, 949 01 | |
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| Nitra, Slovakia, 94901 | |
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| Nove Zamky, Slovakia, 940 01 | |
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| Partizanske, Slovakia, 958 01 | |
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| Presov, Slovakia, 081 01 | |
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| Presov, Slovakia, 080 01 | |
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| Ruzomberok, Slovakia, 034 26 | |
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| Sala, Slovakia, 927 03 | |
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| Sered, Slovakia, 926 00 | |
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| Zvolen, Slovakia, 960 01 | |
| Spain | |
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| Granada, Andalucía, Spain, 18012 | |
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| Sevilla, Andalucía, Spain, 41009 | |
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| Badalona, Barcelona, Spain, 08914 | |
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| Centelles, Barcelona, Spain, 08540 | |
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| Alzira, Comunidad Valenciana, Spain, 46600 | |
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| Santiago de Compostela, Galicia, Spain, 15706 | |
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| Alicante, Spain, 03114 | |
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| Barcelona, Spain | |
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| Madrid, Spain, 28046 | |
| Novartis Investigative Site | |
| Tarragona, Spain, 43350 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01281306 History of Changes |
| Other Study ID Numbers: | CLCZ696A2223, 2010-022326-32 |
| Study First Received: | January 20, 2011 |
| Last Updated: | January 27, 2013 |
| Health Authority: | United States: Food and Drug Administration Argentina: Human Research Bioethics Committee Canada: Therapeutic Products Directorate at Health Canada Hungary: National Institute of Pharmacy India: Drugs Controller General of India Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Agency of Medicine (Agentia Nationala a Medicamentului) South Korea: Korea Food and Drug Administration (KFDA) Slovakia: State Institute for Drug Control Spain: Agencia Espanola del Medicamento y Productos Sanitarios (AEMPS) |
Keywords provided by Novartis:
|
hypertension blood pressure LCZ696 dual-acting neprilysin |
nep inhibitor vasopeptidase angiotensin receptor angiotensin receptor neprilysin inhibitor (ARNi) |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Valsartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013