Morning Hypertension and Preminent Therapy Study

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Preminent (losartan/hydrochlorothiazide combination drug)

• Registration Number: NCT00795847
• Lead Sponsor: Kurume University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Status Verified: 2010-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Preminent	Preminent (losartan/hydrochlorothiazide combination drug)	Patients with blood pressure self-measurement-proven morning hypertension are treated with Preminent 1T qd for 3 months.
2. High-dose losartan	Preminent (losartan/hydrochlorothiazide combination drug)	Patients with blood pressure self-measurement-proven morning hypertension are treated with losartan 100 mg qd for 3 months.

Primary Outcome Measures

Name	Time	Method
Blood pressure level in the morning by blood pressure self-measurement	3 months

Secondary Outcome Measures

Name	Time	Method
Serum levels of potassium, BUN, Creatinine, Uric acid, and Brain natriuretic peptide	3 months

Trial Locations

Locations (1)

Cardio-vascular Medicine, Kurume University; 🇯🇵 Kurume, Fukuoka, Japan