Morning Hypertension and Preminent Therapy Study

Kurume University

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Preminent (losartan/hydrochlorothiazide combination drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT00795847

KurumeU-08058

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

1. Preminent

Experimental group

Description:

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

Treatment:

Drug: Preminent (losartan/hydrochlorothiazide combination drug)

2. High-dose losartan

Active Comparator group

Description:

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

Treatment:

Drug: Preminent (losartan/hydrochlorothiazide combination drug)