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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Preminent | Experimental | Patients with blood pressure self-measurement-proven morning hypertension are treated with Preminent 1T qd for 3 months. |
|
| 2. High-dose losartan | Active Comparator | Patients with blood pressure self-measurement-proven morning hypertension are treated with losartan 100 mg qd for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preminent (losartan/hydrochlorothiazide combination drug) | Drug | Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure level in the morning by blood pressure self-measurement | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum levels of potassium, BUN, Creatinine, Uric acid, and Brain natriuretic peptide | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsutomu Imaizumi, MD, PhD | Kurume University | Study Chair |
| Hisashi Kai, MD, PhD | Kurume University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardio-vascular Medicine, Kurume University | Kurume | Fukuoka | 830-0011 | Japan |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C505809 | hydrochlorothiazide, losartan drug combination |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |