HypertensionPhase 3NCT00289887

Obese Hypertension Study (0954-315)

A Phase 3 study testing Comparator: losartan +/- HCTZ in people with Hypertension, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients. Read more about this study

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Hypertension
What is being tested?: Comparator: losartan +/- HCTZ
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 261 participants
Where: No sites listed yet
Study dates: Feb 2006to Mar 2007
Phase: Phase 3
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 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Obese male and female patients, ages 21-75 years, with high blood pressure

Who cannot join

Patients cannot have any other severe cardiac conditions

About this study

Official title: A Double-Blind, Randomized, Parallel, Efficacy Study Evaluating Losartan Potassium Alone or in Combination With Hydrochlorothiazide Versus Placebo in Obese Patients With Elevated Systolic and Diastolic Blood Pressure

This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.

Conditions: Hypertension
Being tested: Comparator: losartan +/- HCTZ, Comparator: Placebo
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comparator: losartan +/- HCTZDrug
Placebo to losartan once daily for 4 weeks in run-in period. Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment is approximately 16 weeks.
Comparator: PlaceboDrug
Placebo to losartan once daily for 4 weeks in run-in period. Then, placebo to losartan or losartan/HCTZ once daily for approximately 16 weeks.

Study groups in NCT00289887
Study group	Role	What they receive
1	Experimental	Losartan Receives: Drug: Comparator: losartan +/- HCTZ
2	Placebo comparator	Placebo Receives: Drug: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8.
A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Measured: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8
Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8.
A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Measured: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12.
A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Measured: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12
Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12.
A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Measured: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16
Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16.
A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Measured: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16
Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16.
A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Measured: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006Mar 2007

First posted10 Feb 2006 (estimated)
Study startFeb 2006
Primary completionFeb 2007
Study completionMar 2007

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.
Publications (1)Papers the sponsor has linked to this study.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 261 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00289887
Sponsor's protocol ID: 0954-315
Other IDs: MK0954-315, 2006_002
Status last verified: Feb 2022
First submitted: 8 Feb 2006
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov

Publications

Oparil S, Abate N, Chen E, Creager MA, Galet V, Jia G, Julius S, Lerman A, Lyle PA, Pool J, Tershakovec AM. A double-blind, randomized study evaluating losartan potassium monotherapy or in combination with hydrochlorothiazide versus placebo in obese patients with hypertension. Curr Med Res Opin. 2008 Apr;24(4):1101-14. doi: 10.1185/030079908x280716. Epub 2008 Mar 6.
PubMed 18328120

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Hypertension trials

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 Double-Blind, Randomized, Parallel, Efficacy Study Evaluating Losartan Potassium Alone or in Combination With Hydrochlorothiazide Versus Placebo in Obese Patients With Elevated Systolic and Diastolic Blood Pressure
ClinicalTrials.gov ID: NCT00289887
Acronym / sponsor ID: 0954-315
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 261 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Feb 2007 (actual)
Study completion: Mar 2007 (actual)
First posted: 10 Feb 2006 (estimated)
Results: Posted 27 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Comparator: losartan +/- HCTZLosartan
2	Placebo comparator	Drug: Comparator: PlaceboPlacebo

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Obese male and female patients, ages 21-75 years, with high blood pressure

Key exclusion criteria (1 listed)

Patients cannot have any other severe cardiac conditions

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
Comparator: losartan +/- HCTZPlacebo to losartan once daily for 4 weeks in run-in period. Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment is approximately 16 weeks.	Drug	1
Comparator: PlaceboPlacebo to losartan once daily for 4 weeks in run-in period. Then, placebo to losartan or losartan/HCTZ once daily for approximately 16 weeks.	Drug	2

Primary outcome

Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
Time frame: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8
Time frame: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Time frame: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12
Time frame: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16
Time frame: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16
Time frame: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.

Results and safety

Results posted to the registry on 27 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Losartan	127	105
Placebo	134	105

Primary outcome: Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8

Time frame: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM). Least squares mean (Standard Error). Unit: mm Hg

Measure	Losartan n = 119	Placebo n = 117
Value	-12.1 (1.2)	-6.8 (1.2)

Population analysed: An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment.

Primary outcome: Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8

Time frame: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM). Least squares mean (Standard Error). Unit: mm Hg

Measure	Losartan n = 119	Placebo n = 117
Value	-9.7 (0.8)	-6.9 (0.8)

Population analysed: An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment.

Primary outcome: Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12

Time frame: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM). Least squares mean (Standard Error). Unit: mm Hg

Measure	Losartan n = 109	Placebo n = 112
Value	-12.9 (0.8)	-7.1 (0.8)

Population analysed: An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment.

Primary outcome: Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12

Time frame: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM). Least squares mean (Standard Error). Unit: mm Hg

Measure	Losartan n = 109	Placebo n = 112
Value	-16.7 (1.3)	-6.8 (1.3)

Population analysed: An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment.

Adverse events

Time frame: Week 0 through Week 16.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Losartan	1 of 127 (0.8%)	4 of 127 (3.1%)	Not reported
Placebo	1 of 134 (0.7%)	7 of 134 (5.2%)	Not reported

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.
Background: PubMed 18328120Oparil S, Abate N, Chen E, Creager MA, Galet V, Jia G, Julius S, Lerman A, Lyle PA, Pool J, Tershakovec AM. A double-blind, randomized study evaluating losartan potassium monotherapy or in combination with hydrochlorothiazide versus placebo in obese patients with hypertension. Curr Med Res Opin. 2008 Apr;24(4):1101-14. doi: 10.1185/030079908x280716. Epub 2008 Mar 6.

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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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Comparator: losartan +/- HCTZ in people with 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 1 inclusion and 1 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 27 May 2010). 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?

Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8 (time frame: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00289887, which also lists 1 linked publication.

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.