NCT00654745

18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

A Prospective, Open-label, Ambulatory Blood Pressure Monitoring (ABPM) Dose Titration Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil and Amlodipine Based Treatment Regimen in Hypertensive, Type 2 Diabetic Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

Detailed description

This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met.

Conditions

• Type 2 Diabetes
• Hypertension

Interventions

Type	Name	Description
DRUG	Amlodipine	Amlodipine 5 mg tablets , Daily for 3 weeks;
DRUG	amlodipine / olmesartan medoxomil combination	amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg
DRUG	Hydrochlorothiazide	hydrochlorothiazide tablets, 12.5 mg or 25 mg.

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-04-01
• Completion: 2009-06-01
• First posted: 2008-04-09
• Last updated: 2010-07-13
• Results posted: 2010-07-02

Locations

21 sites across 1 country: United States