Morning Hypertension and Preminent Therapy Study

NCT00795847 | Completed Phase 4 DMC

• 1 other identifier: KurumeU-08058
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertensive patients with morning hypertension

Outcome Measures

Primary Outcomes (1)

• Blood pressure level in the morning by blood pressure self-measurement

  3 months

Secondary Outcomes (1)

• Serum levels of potassium, BUN, Creatinine, Uric acid, and Brain natriuretic peptide

  3 months

Study Arms (2)

1. Preminent

EXPERIMENTAL

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

Drug: Preminent (losartan/hydrochlorothiazide combination drug)

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.

Drug: Preminent (losartan/hydrochlorothiazide combination drug)

Interventions

Preminent (losartan/hydrochlorothiazide combination drug) DRUG

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

1. Preminent; 2. High-dose losartan

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of outpatients with morning hypertension (135/85 mmHg)
• Under treatment with any antihypertensive agents

You may not qualify if:

• 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

Sponsors & Collaborators

• Kurume University: lead

Study Sites (1)

Cardio-vascular Medicine, Kurume University

Kurume, Fukuoka, 830-0011, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

hydrochlorothiazide, losartan drug combination; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Tsutomu Imaizumi, MD, PhD

  Kurume University

  STUDY CHAIR

• Hisashi Kai, MD, PhD

  Kurume University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 23, 2011

Record last verified: 2010-11

Locations

JP (1)