HypertensionPhase 3COMFORTNCT00670787
Combination Pill of Losartan Potassium and Hydrochlorothiazide for Improvement of Medication Compliance Trial
A Phase 3 study testing Combination pill of losartan and hydrochlorothiazide in people with Hypertension, run by Kyushu University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Combination pill of losartan and hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2008to Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Medicine and Clinical Science, Kyushu University
Fukuoka, Fukuoka, 812-8582
About this study
Official title: A Randomized Trial to Establish the Effects of Combination Pill of Losartan Potassium and Hydrochlorothiazide on Medication Compliance Among Patients With High Blood Pressure.
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.
Read the detailed description
Despite clear evidence that blood pressure lowering treatment is beneficial for reduction of cardiovascular disease, blood pressure levels are not adequately controlled in many hypertensive patients. More intensive blood pressure lowering treatment is required to achieve maximum reduction of cardiovascular disease. Combination pills of blood pressure lowering drugs could be a safe and effective strategy to achieve blood pressure target but there is no randomized evidence that established the beneficial effects of combination pills of blood pressure lowering drugs. 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
- Being tested
- Combination pill of losartan and hydrochlorothiazide
- Keywords
- Hypertension, combination pill, compliance
- Medical subject headings
- Hypertension, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination pill of losartan and hydrochlorothiazideDrug
Also called Preminent
Combination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning
| Study group | Role | What they receive |
|---|---|---|
| Combination pill | Active comparator | Combination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication compliance
Measured: 6 months
Secondary outcomes (5)
Blood pressure
Measured: 6 months
cost of blood pressure lowering drugs
Measured: 6 months
serious adverse events
Measured: 6 months
adverse events
Measured: 6 months
blood test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyushu University
- Sponsor type
- University, hospital or other
- Investigators
- Kiyoshi Matsumura, MD PhD, Principal investigator, Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670787
- Sponsor's protocol ID
- No. 19041
- Acronym
- COMFORT
- Status last verified
- Mar 2011
- First submitted
- 30 Apr 2008
- Last updated
- 7 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Establish the Effects of Combination Pill of Losartan Potassium and Hydrochlorothiazide on Medication Compliance Among Patients With High Blood Pressure.
- ClinicalTrials.gov ID
- NCT00670787
- Acronym / sponsor ID
- COMFORT / No. 19041
- Conditions
- Hypertension
- Keywords
- Hypertension, combination pill, compliance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Kyushu UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 2 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite clear evidence that blood pressure lowering treatment is beneficial for reduction of cardiovascular disease, blood pressure levels are not adequately controlled in many hypertensive patients. More intensive blood pressure lowering treatment is required to achieve maximum reduction of cardiovascular disease. Combination pills of blood pressure lowering drugs could be a safe and effective strategy to achieve blood pressure target but there is no randomized evidence that established the beneficial effects of combination pills of blood pressure lowering drugs. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination pill | Active comparator | Drug: Combination pill of losartan and hydrochlorothiazideCombination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning |
| 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) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination pill of losartan and hydrochlorothiazideAlso: PreminentCombination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning | Drug | Combination pill |
Primary outcome
Medication compliance
Time frame: 6 months
5 secondary outcomes
Blood pressure
Time frame: 6 months
cost of blood pressure lowering drugs
Time frame: 6 months
serious adverse events
Time frame: 6 months
adverse events
Time frame: 6 months
blood test
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2011.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiyoshi Matsumura, MD PhD principal investigator
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combination pill of losartan and hydrochlorothiazide in people with Hypertension, run by Kyushu University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication compliance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2011.