HypertensionPhase 4NCT00795847
Morning Hypertension and Preminent Therapy Study
A Phase 4 study testing Preminent (losartan/hydrochlorothiazide combination drug) in people with Hypertension, run by Kurume University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Preminent (losartan/hydrochlorothiazide combination drug)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2008to Nov 2010
- Phase
- Phase 4
- 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
- Clinical diagnosis of outpatients with morning hypertension (135/85 mmHg)
- Under treatment with any antihypertensive agents
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Cardio-vascular Medicine, Kurume University
Kurume, Fukuoka, 830-0011
About this study
Official title: The Efficacy and Safety of Losartan/Hydrochlorothiazide Combination Drug (Preminent) in Patients With Morning Hypertension
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.
- Conditions
- Hypertension
- Being tested
- Preminent (losartan/hydrochlorothiazide combination drug)
- Keywords
- Hypertensive patients with morning hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preminent (losartan/hydrochlorothiazide combination drug)Drug
Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 1. Preminent | Experimental | Patients with blood pressure self-measurement-proven morning hypertension are treated with Preminent 1T qd for 3 months. Receives: Drug: Preminent (losartan/hydrochlorothiazide combination drug) |
| 2. High-dose losartan | Active comparator | Patients with blood pressure self-measurement-proven morning hypertension are treated with losartan 100 mg qd for 3 months. Receives: Drug: Preminent (losartan/hydrochlorothiazide combination drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure level in the morning by blood pressure self-measurement
Measured: 3 months
Secondary outcomes (1)
Serum levels of potassium, BUN, Creatinine, Uric acid, and Brain natriuretic peptide
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2010
- Study completionNov 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kurume University
- Sponsor type
- University, hospital or other
- Investigators
- Tsutomu Imaizumi, MD, PhD, Study chair, Kurume UniversityHisashi Kai, MD, PhD, Principal investigator, Kurume University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795847
- Sponsor's protocol ID
- KurumeU-08058
- Status last verified
- Nov 2010
- First submitted
- 20 Nov 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Losartan/Hydrochlorothiazide Combination Drug (Preminent) in Patients With Morning Hypertension
- ClinicalTrials.gov ID
- NCT00795847
- Acronym / sponsor ID
- KurumeU-08058
- Conditions
- Hypertension
- Keywords
- Hypertensive patients with morning hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Kurume UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 21 Nov 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Preminent | Experimental | Drug: Preminent (losartan/hydrochlorothiazide combination drug)Patients with blood pressure self-measurement-proven morning hypertension are treated with Preminent 1T qd for 3 months. |
| 2. High-dose losartan | Active comparator | Drug: Preminent (losartan/hydrochlorothiazide combination drug)Patients with blood pressure self-measurement-proven morning hypertension are treated with losartan 100 mg qd for 3 months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of outpatients with morning hypertension (135/85 mmHg)
- Under treatment with any antihypertensive agents
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Preminent (losartan/hydrochlorothiazide combination drug)Preminent 1T qd (Arm 1) or losartan 100 mg (Arm 2) was given for 3 months. | Drug | 1. Preminent, 2. High-dose losartan |
Primary outcome
Blood pressure level in the morning by blood pressure self-measurement
Time frame: 3 months
1 secondary outcome
Serum levels of potassium, BUN, Creatinine, Uric acid, and Brain natriuretic peptide
Time frame: 3 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 23 Jun 2011.
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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.
Tsutomu Imaizumi, MD, PhD study chair
Kurume University
Hisashi Kai, MD, PhD principal investigator
Kurume University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preminent (losartan/hydrochlorothiazide combination drug) in people with Hypertension, run by Kurume 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 2 inclusion and 8 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 23 Jun 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Blood pressure level in the morning by blood pressure self-measurement (time frame: 3 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 23 Jun 2011.