Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension

Overview

This study assesses the efficacy and safety of co-administration of olmesartan medoxomil plus amlodipine in mild to severe hypertensive patients older than 18 years of age

Full Title of Study: “A Randomized, Double-blind, Placebo-controlled Factorial Study Evaluating the Efficacy and Safety of Co-administration of Olmesartan Medoxomil Plus Amlodipine Compared to Monotherapy in Patients With Mild to Severe Hypertension”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double

Interventions

• Drug: Olmesartan medoxomil
• Drug: Amlodipine

Clinical Trial Outcome Measures

Primary Measures

• Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm

Secondary Measures

• To evaluate the number (%) of patients achieving BP goal.
• To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation

Participating in This Clinical Trial

Inclusion Criteria

• Male or female patients – 18 years of age or older (20% equal to or older than 65 years) – With mild to severe hypertension defined as seated diastolic blood pressure of 95-120 mmHg while off any hypertensive medication Exclusion Criteria:

• Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Daiichi Sankyo, Inc.
• Provider of Information About this Clinical Study
  • Reinilde Heyrman, Daiichi Sankyo