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
Status and phase
Completed
Phase 2
Conditions
Systolic Hypertension
Treatments
Drug: Valsartan
Drug: Placebo
Drug: AHU377
Drug: LCZ696
Details and patient eligibility
About
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).
Enrollment
910 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
910 participants in 7 patient groups
VAL + AHU 400 mg
Experimental group
Description:
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.
Treatment:
Drug: Valsartan
Drug: AHU377
VAL + AHU 200 mg
Experimental group
Description:
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.
Treatment:
Drug: Valsartan
Drug: AHU377
VAL + AHU 100 mg
Experimental group
Description:
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.
Treatment:
Drug: Valsartan
Drug: AHU377
VAL + AHU 50 mg
Experimental group
Description:
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.
Treatment:
Drug: Valsartan
Drug: AHU377
VAL 320 mg
Experimental group
Description:
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.
Treatment:
Drug: Valsartan
LCZ 400 mg
Experimental group
Description:
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.
Treatment:
Drug: LCZ696
Placebo
Experimental group
Description:
Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
Treatment:
Drug: Placebo
Trial contacts and locations
90
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Data sourced from clinicaltrials.gov
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