Morning Hypertension and Preminent Therapy Study

Study Overview
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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.

Official Title
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The Efficacy and Safety of Losartan/Hydrochlorothiazide Combination Drug (Preminent) in Patients With Morning Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Preminent (losartan/hydrochlorothiazide combination drug)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Preminent<br>Patients with blood pressure self-measurement-proven morning hypertension are treated with Preminent 1T qd for 3 months. | Drug: Preminent (losartan/hydrochlorothiazide combination drug)<br>* Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months.<br>|
| Active Comparator: 2. High-dose losartan<br>Patients with blood pressure self-measurement-proven morning hypertension are treated with losartan 100 mg qd for 3 months. | Drug: Preminent (losartan/hydrochlorothiazide combination drug)<br>* Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure level in the morning by blood pressure self-measurement |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of potassium, BUN, Creatinine, Uric acid, and Brain natriuretic peptide |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertensive patients with morning hypertension