Morning Hypertension and Preminent Therapy Study

This study has been completed.
Information provided by:
Kurume University Identifier:
First received: November 20, 2008
Last updated: June 22, 2011
Last verified: November 2010
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 Intervention Phase
Drug: Preminent (losartan/hydrochlorothiazide combination drug)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Losartan/Hydrochlorothiazide Combination Drug (Preminent) in Patients With Morning Hypertension

Resource links provided by NLM:

Further study details as provided by Kurume University:

Primary Outcome Measures:
  • Blood pressure level in the morning by blood pressure self-measurement [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum levels of potassium, BUN, Creatinine, Uric acid, and Brain natriuretic peptide [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 216
Study Start Date: November 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00795847

Cardio-vascular Medicine, Kurume University
Kurume, Fukuoka, Japan, 830-0011
Sponsors and Collaborators
Kurume University
Study Chair: Tsutomu Imaizumi, MD, PhD Kurume University
Principal Investigator: Hisashi Kai, MD, PhD Kurume University
  More Information

Responsible Party: Tsutomu Imaizumi/Chair of Cardio-vascular Medicine Kurume University, Cardio-vascular Medicine Kurume University Identifier: NCT00795847     History of Changes
Other Study ID Numbers: KurumeU-08058 
Study First Received: November 20, 2008
Last Updated: June 22, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kurume University:
Hypertensive patients with morning hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Therapeutic Uses processed this record on May 02, 2016