Phase 2
N=389
Efficacy and Safety of LCZ696 Compared to Placebo in Patients With Essential Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01193101 ↗Enrolled (actual)
389
Serious AEs
0.8%
Results posted
Aug 2015
Primary outcome: Primary: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) — -11.53; -10.98; -12.45; -3.69 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LCZ696 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) |
-11.53; -10.98; -12.45; -3.69 | — |
| SECONDARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) |
-16.83; -17.54; -20.35; -4.97 | — |
| SECONDARY Change From Baseline in 24 Hour Mean Ambulatory DBP and SBP |
-8.34; -9.33; -9.69; 0.28; -13.07; -15.18 | — |
| SECONDARY Change From Baseline in Daytime Mean Ambulatory DBP and SBP |
-8.46; -8.65; -9.77; -0.13; -13.29; -14.62 | — |
| SECONDARY Change From Baseline in Nighttime Mean Ambulatory DBP and SBP |
-7.96; -10.36; -9.47; 0.97; -12.27; -16.14 | — |
| SECONDARY Change From Baseline in Mean Sitting Pulse Pressure |
-5.11; -6.49; -7.82; -1.09 | — |
| SECONDARY Change From Baseline in Mean Ambulatory Pulse Pressure |
-4.68; -5.84; -6.31; -0.08 | — |
| SECONDARY Number of Participants Who Achieved a Successful Response in msDBP |
65; 64; 67; 24 | — |
| SECONDARY Number of Participants Who Achieved a Successful Response in msSBP |
59; 62; 66; 27 | — |
| SECONDARY Number of Participants Who Achieved Successful BP Control |
47; 48; 52; 14 | — |
| SECONDARY Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP |
0.95; 1.32; 1.28; 0.76; 1.03; 0.90 | — |
| SECONDARY Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP |
0.98; 1.29; 1.16; 1.01; 1.26; 1.28 | — |
| SECONDARY Change From Week 8 to Week 9 in msDBP and msSBP After Single-blind Placebo Withdrawal at Week 8 |
4.8; 5.1; 5.6; -0.6; 8.0; 8.8 | — |
Summary
This study is a phase 2 study in patients with essential hypertension.
Eligibility Criteria
Inclusion Criteria
- Patients must give written informed consent before any assessment is performed.
- Patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy (mean sitting diastolic blood pressure ≥ 95 mmHg and < 110 mmHg, and mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg).
- Patients must be willing and able to undergo ambulatory blood pressure monitoring for a 24-hr period at the beginning and the end of the 8-week treatment.
- Patient must be able to communicate and comply with all study requirements and demonstrate good medication compliance.
Exclusion Criteria
- Patients with severe hypertension.
- Patients with history of angioedema, drug-related or otherwise
- Pregnant or nursing women
- Women of child-bearing potential , who do not use adequate birth control methods
- History or evidence of a secondary form of hypertension.
- History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, TIA, carotid artery stenosis, aortic aneurysm, or peripheral arterial disease.
- Diabetes mellitus.
- Previous or current diagnosis of heart failure (NYHA Class II-IV).
- Clinically significant valvular heart disease at the time of screening.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01193101). 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.