HypertensionNCT01368185
Impact of MK-0954A on Uric Acid in the Management of Hypertension (MK-0954A-366)
An observational study of Hypertension, run by Organon and Co.
Trial summary
This was a retrospective, chart review, observational study to assess the effect of MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg [Hyzaar(R)]) treatment for a period of at least three months on serum uric acid levels. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hypertension
- How many people
- 1,705 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Aug 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data from 33 physicians from different levels of hospitals were invited to provide information on patients who received MK-0954A and had pre- and post-treatment serum uric acid and lipid profile reports during the study period. Each physician could provide up to 30 clinical charts of patients matching the inclusion criteria for the study.
Who may be able to join
- Participant was >20 years and <75 years of age on the index date (i.e., the date of initiating MK-0954A therapy)
- Diagnosed with hypertension and had received MK-0954A 50/12.5 mg for at least 3 months
- Had at least one serum uric acid measurements at baseline and one at 3 months after using MK-0954A 50/12.5 mg
- Had the following records documented in the chart during the data collection period:
- medical history and co-morbidities (if available)
- sitting blood pressure, serum uric acid, lipid profile test results before and after using MK-0954A 50/12.5 mg
- serum electrolytes, serum creatinine, and pre-meal sugar (if available)
- prescription information of all antihypertensive regimens
Who cannot join
- Had been treated with diuretic or angiotensin-receptor blockers (ARBs) 2 weeks before initiated treatment with MK-0954A 50/12.5 mg
- Serum creatinine >2 mg/dL
About this study
Official title: A Retrospective Survey to Evaluate the Impact of Hyzaar on Uric Acid in the Management of Hypertensive Patients in Normal Practice
This was a retrospective, chart review, observational study to assess the effect of MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg [Hyzaar(R)]) treatment for a period of at least three months on serum uric acid levels.
- Conditions
- Hypertension
- Keywords
- Essential hypertension Uric acid Retrospective Hyzaar
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Uric Acid (SUA) Level
SUA at baseline and Month 3.
Measured: Baseline and Month 3
Secondary outcomes (3)
The Percentage of Patients With Hyperuricemia
Hyperuricemia was defined as SUA >6.6mg/dL in females and >7.7mg/dL in males.
Measured: Baseline and Month 3
Diastolic Blood Pressure (DBP)
DBP at baseline and month 3.
Measured: Baseline and Month 3
Systolic Blood Pressure (SBP)
SBP at baseline and month 3.
Measured: Baseline and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startNov 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368185
- Sponsor's protocol ID
- 0954A-366
- Other IDs
- MK-0954A-366
- Status last verified
- Feb 2022
- First submitted
- 6 Jun 2011
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Survey to Evaluate the Impact of Hyzaar on Uric Acid in the Management of Hypertensive Patients in Normal Practice
- ClinicalTrials.gov ID
- NCT01368185
- Acronym / sponsor ID
- 0954A-366
- Conditions
- Hypertension
- Keywords
- Essential hypertension Uric acid Retrospective Hyzaar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,705 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 7 Jun 2011 (estimated)
- Results
- Posted 1 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a retrospective, chart review, observational study to assess the effect of MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg [Hyzaar(R)]) treatment for a period of at least three months on serum uric acid levels.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | –Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data from 33 physicians from different levels of hospitals were invited to provide information on patients who received MK-0954A and had pre- and post-treatment serum uric acid and lipid profile reports during the study period. Each physician could provide up to 30 clinical charts of patients matching the inclusion criteria for the study.
Key inclusion criteria (8 listed)
- Participant was >20 years and <75 years of age on the index date (i.e., the date of initiating MK-0954A therapy)
- Diagnosed with hypertension and had received MK-0954A 50/12.5 mg for at least 3 months
- Had at least one serum uric acid measurements at baseline and one at 3 months after using MK-0954A 50/12.5 mg
- Had the following records documented in the chart during the data collection period:
Key exclusion criteria (2 listed)
- Had been treated with diuretic or angiotensin-receptor blockers (ARBs) 2 weeks before initiated treatment with MK-0954A 50/12.5 mg
- Serum creatinine >2 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Uric Acid (SUA) Level
Time frame: Baseline and Month 3
SUA at baseline and Month 3.
3 secondary outcomes
The Percentage of Patients With Hyperuricemia
Time frame: Baseline and Month 3
Diastolic Blood Pressure (DBP)
Time frame: Baseline and Month 3
Systolic Blood Pressure (SBP)
Time frame: Baseline and Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Organon and Co.
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 8 inclusion and 2 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Uric Acid (SUA) Level (time frame: Baseline and Month 3). 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 9 Feb 2022.