Morning Hypertension and Preminent Therapy Study

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795847
• Other study ID #: KurumeU-08058
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2008
• Last updated: June 22, 2011
• Start date: November 2008
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: Kurume University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Preminent (losartan/hydrochlorothiazide combination drug)
Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months.

Locations

Country	Name	City	State
Japan	Cardio-vascular Medicine, Kurume University	Kurume	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Kurume University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure level in the morning by blood pressure self-measurement		3 months	Yes
Secondary	Serum levels of potassium, BUN, Creatinine, Uric acid, and Brain natriuretic peptide		3 months	Yes