Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine
Source: ClinicalTrials.gov NCT01663233 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (maSBP) |
-13.93; -0.82 | — |
| SECONDARY Change in Mean 24-hour ABPM Diastolic Blood Pressure (maDBP) |
-8.03; -0.33 | — |
| SECONDARY Change in Mean Sitting Systolic Blood Pressure (msSBP) |
-19.60; -9.34 | — |
| SECONDARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) |
-9.22; -3.96 | — |
| SECONDARY Change in Sitting Pulse Pressure (PP) |
-10.31; -5.46 | — |
| SECONDARY Number of Participants Achieving Systolic and Diastolic Blood Pressure Control (< 140/90 mmHg) |
89; 46 | — |
| SECONDARY Number of Participants Achieving Successful Response in msSBP (< 140 mmHg or a Reduction ≥ 20 mmHg From Baseline) |
98; 53 | — |
| SECONDARY Number of Participants Achieving Successful Response in msDBP (< 90 mmHg or a Reduction ≥ 10 mmHg From Baseline) |
112; 95 | — |
| SECONDARY Number of Participants With Adverse Event |
26; 29; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
Patients must give written informed consent and have a diagnosis of hypertension:
Untreated patients must have an msSBP ≥ 150 mmHg and < 180 mmHg at both Visit 1 and Visit 101. Pre-treated patients must have an msSBP ≥ 145 mmHg and < 180 mmHg after wash out at Visit 101. All patients must have an office msSBP ≥ 145 mmHg and < 180 mmHg at the completion of the 4-week run-in epoch (at the randomization visit (Visit 201).
Patients must successfully complete ABPM and pass technical requirements at Visit 201.
Exclusion Criteria
Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg).
History of angioedema, drug-related or otherwise. History or evidence of a secondary form of hypertension. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.
History of myocardial infarction, coronary bypass surgery or PCI during the 12 months prior to Visit 1
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01663233). 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.