Morning Hypertension and Preminent Therapy Study

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00795847

Enrollment

216

Registered

2008-11-21

Start date

2008-11-30

Completion date

2010-11-30

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertensive patients with morning hypertension

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.

Interventions

DRUGPreminent (losartan/hydrochlorothiazide combination drug)

Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Blood pressure level in the morning by blood pressure self-measurement	3 months

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026