Trial intelligence / Profile preview

Telmisartan/HCTZ vs Amlodipine in Uncontrolled Hypertension

NCT00509470Phase 4

Key facts

Status: Completed
Start: Jul 2007
Primary completion: Jun 2012
Countries: 1
Sponsor: The University of Tokyo
Modality: Small Molecules

Drugs: telmisartanhydrochlorothiazide
Conditions: essential hypertension

Overview

Phase 4, randomised, open-label trial of telmisartan and hydrochlorothiazide in essential hypertension (2 arms), sponsored by The University of Tokyo. Primary endpoint: Changes in office blood pressure at 12 weeks. Started Jul 2007; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Telmisartan + HCTZ
Telmisartan (40-80 mg) + HCTZ (12.5 mg)
Amlodipine
Amlodipine 5 mg (continued)

Who it enrols

Patients with essential hypertension uncontrolled on amlodipine 5mg/day for >3 months.

Endpoints

Primary

Changes in office blood pressure12 weeks

Secondary

Home blood pressure in early morning and before going to bed12 weeks
Changes in uric acid12 weeks
Changes in total cholesterol12 weeks
Changes in HDL cholesterol12 weeks
Changes in LDL cholesterol12 weeks
Changes in triglyceride12 weeks
Changes in fasting plasma glucose12 weeks
Changes in hemoglobin A1c12 weeks

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