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

Completed · Phase 2 · Has a placebo group

Conditions studied: Systolic Hypertension

In brief

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).

Key facts

Study ID

NCT01281306

Run by

Novartis Pharmaceuticals

People needed

910

Starts

2011-01-01

Expected to finish

2011-12-01

Last updated by the study team

2016-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Metairie, Louisiana, United States
• Novartis Investigative Site — Belzoni, Mississippi, United States
• Novartis Investigative Site — Jackson, Mississippi, United States
• Novartis Investigative Site — Jackson, Mississippi, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Henderson, Nevada, United States
• Novartis Investigative Site — Las Vegas, Nevada, United States
• Novartis Investigative Site — Buffalo, New York, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Greensboro, North Carolina, United States
• Novartis Investigative Site — Greensboro, North Carolina, United States
• Novartis Investigative Site — Shelby, North Carolina, United States
• Novartis Investigative Site — Erie, Pennsylvania, United States
• Novartis Investigative Site — Bryan, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Buenos Aires, Buenos Aires, Argentina
• Novartis Investigative Site — Caba, Buenos Aires, Argentina
• Novartis Investigative Site — Lanus, Buenos Aires, Argentina
• Novartis Investigative Site — Caba, Buenos Aires F.D., Argentina
• Novartis Investigative Site — Corrientes, Corrientes Province, Argentina
• Novartis Investigative Site — Córdoba, Córdoba Province, Argentina
• Novartis Investigative Site — Clearwater, Florida, United States

Full record on ClinicalTrials.gov

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