Phase 4
Completed N=60
To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone
Hypertension · High Blood Pressure
Source: ClinicalTrials.gov NCT01070043 ↗
Enrolled (actual)
60
Serious AEs
2.4%
Results posted
Oct 2011
Primary outcomePrimary: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement — 150.26; 141.14; 133.79; 133.68 mmHg
Summary
The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood pressure in Taiwanese patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement |
150.26; 141.14; 133.79; 133.68; -16.48; -7.23 | — |
| PRIMARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement |
92.12; 89.98; 82.29; 86.73; -9.83; -2.65 | — |
| SECONDARY Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours |
144.38; 139.76; 129.67; 131.11; -14.71; -6.39 | — |
| SECONDARY Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase |
86.95; 87.90; 79.29; 82.94; -7.67; -3.56 | — |
| SECONDARY Number of Participants With Adverse Events During Double-blind Phase |
9; 15; 7; 11; 9; 15 | — |
Eligibility Criteria
Inclusion Criteria
- Participants over 18 years of age with hypertension defined as sitting systolic blood pressure between 140 mmHg and 180 mmHg or sitting diastolic blood pressure between 90 mmHg and 120 mmHg.
- High risk participants ( defined as having: (diabetes mellitus, chronic renal disease, Framingham 10-year risk score >10%, established coronary artery disease (CAD), or CAD equivalents including carotid artery disease, peripheral arterial disease (PAD), abdominal aortic aneurysm (AAA))with hypertension defined as sitting systolic blood pressure between 130 mmHg and 180 mmHg or sitting diastolic blood pressure between 80 mmHg and 120 mmHg.
Exclusion Criteria
- Known or suspected secondary hypertension
- Known New York Heart Association (NYHA) functional class IV Heart Failure
- History of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 3 months
- Clinically significant valvular disease
- Women who are pregnant, intend to become pregnant or are breastfeeding
- Participants who have severe medical condition(s) that in the view of the Investigator prohibits participation in the study
- Participants who have hypersensitivity to the investigational/ reference drug or any of the components in the formulation.
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01070043). 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.