Phase 3
Completed N=1,468
Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension
Source: ClinicalTrials.gov NCT00425373 ↗Enrolled (actual)
1,468
Serious AEs
0.3%
Results posted
Feb 2011
Primary outcomePrimary: Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8) — -13.5; -16.5; -12.6; -17.0 mm Hg
Summary
The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies, and placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8) |
-13.5; -16.5; -12.6; -17.0; -8.5; -8.8 | — |
| SECONDARY Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8) |
-16.7; -22.0; -16.9; -22.9; -9.3; -9.5 | — |
| SECONDARY Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8) |
77.4; 88.0; 80.6; 86.4; 52.1; 47.9 | — |
| SECONDARY Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8) |
67.3; 82.6; 72.5; 80.9; 46.2; 41.1 | — |
| SECONDARY Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8) |
55.3; 75.4; 59.4; 72.2; 33.1; 30.1 | — |
Eligibility Criteria
Inclusion criteria
- Patients with essential hypertension measured by electronic hemodynamometer. - - Patients must satisfy the following criteria.
- MSDBP 20 and = 8.0% at Visit 1.
- Patients with or with a history of malignant tumors including leukemia and lymphoma, treated or untreated, within the past 5 years of Visit 1 whether or not there is evidence of local recurrence or metastases (except for localized basal cell carcinoma of the skin).
- Patients with any severe, life-threatening disease within the past 5 years. Patients with a history of autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus.
- Any surgical or medical condition, which in the opinion of the investigator or subinvestigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirement of the study or completing the trial period.
- Patients who have with or with a history of drug or alcohol abuse within the last 2 years of Visit 1. Patients who have received other investigational product within 12 weeks of Visit 1.
- Any chronic inflammatory condition needing chronic anti-inflammatory drug therapy.
- Persons directly involved in the execution of this study.
- Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or subinvestigator.
Data sourced from ClinicalTrials.gov (NCT00425373). 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.