drugset / Trial / NCT01625494
Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective: \- To assess the proportion of patients with controlled Office Blood Pressure Measurements (OBPM), defined as Systolic blood pressure \< 140 mmHg and Diastolic blood pressure \<90mmHg, at the end of the study Secondary Objectives: * To examine over time the antihypertensive effect of the 4 doses of the fixed combination therapy irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and DBP (diastolic blood pressure) * To examine the proportion of patients with controlled OBPM (systolic BP\<140 mm Hg and diastolic BP\<90 mmHg) of the different dose groups over time * To determine the incidence and severity of adverse events.
Timeline
- Start
- 2012-05
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 5 mg | Oral |
| Subject | Amlodipine | Other / unclassified | 10 mg | Oral |
| Subject | Irbesartan | Small molecule | 150 mg | Oral |
| Subject | Irbesartan | Small molecule | 300 mg | Oral |