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Morning Hypertension and Preminent Therapy Study

This study has been completed.
Sponsor:
Information provided by:
Kurume University
ClinicalTrials.gov Identifier:
NCT00795847
First received: November 20, 2008
Last updated: June 22, 2011
Last verified: November 2010
History of Changes
  Purpose

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
Hypertension
 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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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

ClinicalTrials.gov processed this record on May 16, 2013