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Morning Hypertension and Preminent Therapy Study

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ClinicalTrials.gov Identifier: NCT00795847
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Kurume University

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 Type : Interventional  (Clinical Trial)
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 : November 2008
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Blood pressure level in the morning by blood pressure self-measurement [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Serum levels of potassium, BUN, Creatinine, Uric acid, and Brain natriuretic peptide [ Time Frame: 3 months ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795847


Locations
Japan
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

Responsible Party: Tsutomu Imaizumi/Chair of Cardio-vascular Medicine Kurume University, Cardio-vascular Medicine Kurume University
ClinicalTrials.gov Identifier: NCT00795847     History of Changes
Other Study ID Numbers: KurumeU-08058
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: November 2010

Keywords provided by Kurume University:
Hypertensive patients with morning hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Losartan
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists