Morning Hypertension and Preminent Therapy Study

• Sponsor: Kurume University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00795847
• Collaborator: (none)
• Enrollment: 216
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Preminent (losartan/hydrochlorothiazide combination drug)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 216 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficacy and Safety of Losartan/Hydrochlorothiazide Combination Drug (Preminent) in Patients With Morning Hypertension
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1. Preminent Patients with blood pressure self-measurement-proven morning hypertension are treated with Preminent 1T qd for 3 months.	Drug: Preminent (losartan/hydrochlorothiazide combination drug); Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months.
Active Comparator: 2. High-dose losartan 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); Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months.

Outcome Measures

Primary Outcome Measures

1. Blood pressure level in the morning by blood pressure self-measurement [3 months]

Secondary Outcome Measures

1. Serum levels of potassium, BUN, Creatinine, Uric acid, and Brain natriuretic peptide [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardio-vascular Medicine, Kurume University	Kurume	Fukuoka	Japan	830-0011

Sponsors and Collaborators

• Kurume University

Investigators

• Study Chair: Tsutomu Imaizumi, MD, PhD, Kurume University
• Principal Investigator: Hisashi Kai, MD, PhD, Kurume University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00795847
• Other Study ID Numbers: KurumeU-08058
• First Posted: Nov 21, 2008
• Last Update Posted: Jun 23, 2011
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: Hypertensive patients with morning hypertension
• Additional relevant MeSH terms: Hypertension; Losartan; Hydrochlorothiazide

Study Results

No Results Posted as of Jun 23, 2011