Phase 2
N=1,328
Efficacy and Safety of LCZ696A in Patients With Essential Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00549770 ↗Enrolled (actual)
1,328
Serious AEs
0.2%
Results posted
Aug 2015
Primary outcome: Primary: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) — -9.97; -12.92; -13.63; -9.14 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LCZ696 (Drug); Valsartan (Drug); AHU377 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) |
-9.97; -12.92; -13.63; -9.14; -9.95; -10.93 | — |
| SECONDARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) |
-13.75; -18.70; -20.17; -12.44; -13.42; -14.16 | — |
| SECONDARY Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP |
-3.80; -6.78; -8.32; -4.56; -6.25; -7.13 | — |
| SECONDARY Change From Baseline in Daytime maDBP and maSBP |
-4.05; -6.91; -7.80; -4.78; -7.40; -7.47 | — |
| SECONDARY Change From Baseline in Nighttime maDBP and maSBP |
-2.87; -7.73; -6.93; -4.04; -4.18; -6.17 | — |
| SECONDARY Percentage of Participants Who Achieved a Successful Response in msDBP |
53.90; 69.64; 74.12; 51.53; 55.83; 63.19 | — |
| SECONDARY Percentage of Participants Who Achieved a Successful Response in msSBP |
55.84; 63.69; 72.35; 51.53; 51.53; 57.06 | — |
| SECONDARY Percentage of Participants Who Achieved Successful Control in msDBP |
47.40; 60.12; 65.88; 45.40; 47.85; 56.44 | — |
| SECONDARY Percentage of Participants Who Achieved Successful Control in msSBP |
47.40; 56.55; 62.94; 45.40; 42.33; 53.37 | — |
Summary
This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.
Eligibility Criteria
Inclusion Criteria
- Male or females from 18 up to and including 75 years
- Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs; therapy with a fixed dose combination of two active substances represents 2 drugs)
- Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2).
- Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP> 95 mmHg at baseline (Visit 3);
Exclusion Criteria
- Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg)
- History of angioedema, drug-related or otherwise, as reported by the patient
- Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)
- History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc.
- History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease
Data sourced from ClinicalTrials.gov (NCT00549770). 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.