Morning Hypertension and Preminent Therapy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. Preminent

Patients with blood pressure self-measurement-proven morning hypertension are treated with Preminent 1T qd for 3 months.

Group Type EXPERIMENTAL

Preminent (losartan/hydrochlorothiazide combination drug)

Intervention Type DRUG

Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months.

2. High-dose losartan

Patients with blood pressure self-measurement-proven morning hypertension are treated with losartan 100 mg qd for 3 months.

Group Type ACTIVE_COMPARATOR

Preminent (losartan/hydrochlorothiazide combination drug)

Intervention Type DRUG

Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months.

Interventions

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Preminent (losartan/hydrochlorothiazide combination drug)

Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of outpatients with morning hypertension (135/85 mmHg)
* Under treatment with any antihypertensive agents

Exclusion Criteria

* Poorly controlled hypertension (DBP\>120 mmHg)
* Poorly controlled diabetes (HbA1c\>9.0%
* Gout or hyperuricemia (UA\>8.0 mg/dL)
* Serum Cr\>2.0 mg/dL
* Serum K\>5.5 mmol/L
* Liver dysfunction (ALT\>90 IU/L and/or g-GTP\>14o IU/L)
* Secondary hypertension
* Patients who have contraindication for losartan and/or thiazide diuretics

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No