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NCT Number: NCT00795847

Morning Hypertension and Preminent Therapy Study

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardio-vascular Medicine, Kurume University

Kurume, Fukuoka, 830-0011, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preminent (losartan/hydrochlorothiazide combination drug)

Drug

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

Primary outcomes

  1. Blood pressure level in the morning by blood pressure self-measurement

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Kurume University

Other

Registry information

Official study title

The Efficacy and Safety of Losartan/Hydrochlorothiazide Combination Drug (Preminent) in Patients With Morning Hypertension

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 21, 2008
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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