Phase 2
Completed N=907
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
Systolic Hypertension
Source: ClinicalTrials.gov NCT01281306 ↗
Enrolled (actual)
907
Serious AEs
0.9%
Results posted
Aug 2015
Primary outcomePrimary: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) — -20.89; -23.55; -21.26; -19.31 mmHg
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) |
-20.89; -23.55; -21.26; -19.31; -16.13; -21.78 | — |
| SECONDARY Change From Baseline in Mean Diastolic Blood Pressure (msDBP) |
-8.47; -9.76; -8.04; -7.15; -7.28; -9.61 | — |
| SECONDARY Change From Baseline in Mean 24 Hour Ambulatory SBP (maSBP) and Mean 24 Hour Ambulatory DBP (maDBP) |
-12.14; -15.66; -14.33; -11.36; -9.59; -12.98 | — |
| SECONDARY Change From Baseline in Daytime maSBP and maDBP |
-12.62; -15.85; -14.43; -11.50; -9.60; -13.32 | — |
| SECONDARY Change From Baseline in Nighttime maSBP and maDBP |
-11.57; -15.27; -14.74; -10.80; -8.88; -12.34 | — |
| SECONDARY Change From Baseline in Mean Sitting Pulse Pressure |
-12.39; -13.91; -13.18; -12.01; -8.80; -12.18 | — |
| SECONDARY Change From Baseline in Mean Ambulatory Pulse Pressure |
-6.23; -8.51; -7.71; -6.00; -4.40; -6.84 | — |
| SECONDARY Change From Baseline in maSBP and maDBP in Dippers |
-11.43; -15.59; -12.04; 10.60; -9.85; -13.09 | — |
| SECONDARY Change From Baseline in maSBP and maDBP in Non-dippers |
-12.81; -16.08; -16.37; -12.17; -9.73; -13.12 | — |
| SECONDARY Change From Baseline in msSBP and msDBP in Participants < 65 Years of Age |
-20.95; -24.45; -20.94; -18.09; -16.96; -21.06 | — |
| SECONDARY Change From Baseline in msSBP and msDBP in Participants >= 65 Years of Age |
-20.93; -22.66; -21.72; -20.64; -15.48; -22.83 | — |
| SECONDARY Change From Baseline in maSBP and maDBP in Participants < 65 Years of Age |
-12.16; -15.06; -14.42; -10.39; -9.55; -13.98 | — |
| SECONDARY Change From Baseline in maSBP and maDBP in Participants >= 65 Years of Age |
-12.10; -16.08; -14.20; -12.25; -9.73; -11.88 | — |
| SECONDARY Number of Participants Who Achieved Blood Pressure Control and Blood Pressure Response |
72; 86; 71; 58; 57; 76 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events and Death |
40; 31; 29; 25; 38; 42 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01281306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.