Combination Pill of Losartan Potassium and Hydrochlorothiazide for Improvement of Medication Compliance Trial

NCT00670787 | Completed Phase 3 DMC

• 1 other identifier: No. 19041
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether combination pill of losartan potassium and hydrochlorothiazide will improve medication compliance among patients with high blood pressure.

Conditions

Hypertension

Keywords

Hypertension; combination pill; compliance

Outcome Measures

Primary Outcomes (1)

• Medication compliance

  6 months

Secondary Outcomes (5)

• Blood pressure

  6 months

• cost of blood pressure lowering drugs

  6 months

• serious adverse events

  6 months

• adverse events

  6 months

• blood test

  6 months

Study Arms (2)

Combination pill

ACTIVE COMPARATOR

Combination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning

Drug: Combination pill of losartan and hydrochlorothiazide

Control group

NO INTERVENTION

combination therapy of angiotensin receptor antagonists (losartan potassium 50mg, candesartan 8mg, valsartan 80mg, telmisartan 40mg or olmesartan 20mg) and thiazide or thiazide-like diuretics (hydrochlorothiazide 6.25-12.5mg, trichlormethiazide 0.5-1.0mg, indapamide 0.5-1.0mg or chlorthalidone 6.25-12.5mg)

Interventions

Combination pill of losartan and hydrochlorothiazide DRUG

Combination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning

Also known as: Preminent

Combination pill

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 20 years or above
• Hypertension defined as blood pressure levels of \>/=140/90mmHg or current use of blood pressure lowering drugs
• Able to commence combination therapy of angiotensin receptor antagonists and diuretics

You may not qualify if:

• Blood pressure measurements of \>/=200/120mmHg
• Previous serious adverse events due to angiotensin receptor antagonists or diuretics
• Known or possible pregnancy
• Known severe liver dysfunction
• Known severe kidney disease
• Known contraindication to angiotensin receptor antagonists or diuretics
• Taking \>/=4 tablets except for angiotensin receptor antagonists
• ACE inhibitors, thiazide or thiazide-like diuretics in the morning
• Current participation in another clinical trial
• A high likelihood that the patient is not suitable for the study treatment

Sponsors & Collaborators

• Kyushu University: lead

Study Sites (1)

Department of Medicine and Clinical Science, Kyushu University

Fukuoka, Fukuoka, 812-8582, Japan

Location

MeSH Terms

Conditions

Hypertension; Patient Compliance

Interventions

Losartan; Hydrochlorothiazide; hydrochlorothiazide, losartan drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kiyoshi Matsumura, MD PhD

  Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 2, 2008
• Study Start: June 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: February 1, 2011
• Last Updated: March 7, 2011

Record last verified: 2011-03

Locations

JP (1)