Morning Hypertension and Preminent Therapy Study
NCT00795847 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 216
Last updated 2011-06-23
Summary
It is difficult to control morning hypertension in practical clinical situation. Angiotensin receptor blocker (ARB) and thiazide are suggested to be effective to maintain the antihypertensive effects for 24 hours. However, monotherapy sometimes is not enough to control blood pressure level in the next morning and there are little evidence of the combination therapy for morning hypertension. The investigators hypothesized that a losartan 50 mg/hydrochlorothiazide 12.5 mg combination drug, Preminent, is effective and safe for controling morning hypertension, compared with high-dose of losartan 100 mg, in Japanese. Patients with morning hypertension were randomized to preminent treatment group or high-dose losartan treatment group. The efficacy and safety were compared after 3-month treatment.
Conditions
Interventions
- DRUG
-
Preminent (losartan/hydrochlorothiazide combination drug)
Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months.
Sponsors & Collaborators
-
Kurume University
lead OTHER
Principal Investigators
-
Tsutomu Imaizumi, MD, PhD · Kurume University
-
Hisashi Kai, MD, PhD · Kurume University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-11-30
- Primary Completion
- 2010-11-30
- Completion
- 2010-11-30
Countries
- Japan
Study Locations
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