HypertensionPhase 4NCT00496834

LAAS (Losartan Anti-Atherosclerosis Study)(0954-330)(COMPLETED)

A Phase 4 study testing losartan potassium, Comparator: carvedilol and Comparator: losartan (+) hydrochlorothiazide (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.

Official record

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Trial summary

The primary objective of this study is to evaluate efficacy, arterial stiffness measured by Pulse Wave Velocity (PWV) of Losartan potassium group compared to Carvedilol group after 24 weeks of treatment in patients with the essential hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: losartan potassium, Comparator: carvedilol and Comparator: losartan (+) hydrochlorothiazide (HCTZ)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 201 participants
Where: No sites listed yet
Study dates: 1 Feb 2008to 1 Sep 2009
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or Female adults, 18 years or over
Essential Hypertension with mean SBP (systolic blood pressure) ≥ 140 mm Hg or mean DBP (diastolic blood pressure) ≥ 90 mm Hg* when blood pressure is measured at Visit 1(week -2) and at Visit 2(week 0).
If diabetes patients, mean SBP ≥ 130 mm Hg or mean DBP ≥ 80 mm Hg (Mean of blood pressure values measured consecutively at least 2 minutes apart)
Patient who is willing to, and is able to sign the informed consent form

Who cannot join

Patient Is Pregnant Or Breastfeeding, Or Expecting To Conceive Within The Projected Duration Of The Study
Patient Has Known Or Suspected Secondary Hypertension Of Any Etiology
Patient has history of malignant hypertension
Patient has history of cerebrovascular accident (cerebral infarction) or myocardiac infarction within the last 6 months
Patient takes antihypertensive drugs

About this study

Official title: A Randomized, Open-label, Comparative, Non-inferiority, Multicenter Study to Compare Efficacy of Losartan Potassium Group and Carvedilol Group on Arterial Stiffness in Essential Hypertension Patients

Conditions: Hypertension
Being tested: losartan potassium, Comparator: carvedilol, Comparator: losartan (+) hydrochlorothiazide (HCTZ), Comparator: carvedilol (+) hydrochlorothiazide
Medical subject headings: Hypertension

What participants receive

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

losartan potassiumDrug
Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
Comparator: carvedilolDrug
Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
Comparator: losartan (+) hydrochlorothiazide (HCTZ)Drug
Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)
Comparator: carvedilol (+) hydrochlorothiazideDrug
Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)

Study groups in NCT00496834
Study group	Role	What they receive
1	Experimental	Losartan or Losartan/HCTZ Receives: Drug: losartan potassium; Drug: Comparator: losartan (+) hydrochlorothiazide (HCTZ)
2	Active comparator	Carvedilol or Carvedilol/HCTZ Receives: Drug: Comparator: carvedilol; Drug: Comparator: carvedilol (+) hydrochlorothiazide

What is being measured

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

Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
Analysis was performed in the modified intention to treat (mITT) population.
Measured: Baseline and 24 Weeks
PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
Analysis was performed in the per protocol (PP) population which additionally excludes certain protocol violations as described in the analysis plan.
Measured: Baseline and 24 Weeks

Secondary outcomes (2)

Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
Measured: Baseline and 24 weeks
Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
Measured: Baseline and 24 weeks

Timeline

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

1 Feb 20081 Sep 2009

First posted4 Jul 2007 (estimated)
Study start1 Feb 2008
Primary completion1 Sep 2009
Study completion1 Sep 2009

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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00496834
Sponsor's protocol ID: 0954-330
Other IDs: 2007_015
Status last verified: Feb 2022
First submitted: 3 Jul 2007
Last updated: 22 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

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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Study at a glance

From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Comparative, Non-inferiority, Multicenter Study to Compare Efficacy of Losartan Potassium Group and Carvedilol Group on Arterial Stiffness in Essential Hypertension Patients
ClinicalTrials.gov ID: NCT00496834
Acronym / sponsor ID: 0954-330
Conditions: Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 1 Feb 2008 (actual)
Primary completion: 1 Sep 2009 (actual)
Study completion: 1 Sep 2009 (actual)
First posted: 4 Jul 2007 (estimated)
Results: Posted 15 Dec 2010

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: losartan potassium, Drug: Comparator: losartan (+) hydrochlorothiazide (HCTZ)Losartan or Losartan/HCTZ
2	Active comparator	Drug: Comparator: carvedilol, Drug: Comparator: carvedilol (+) hydrochlorothiazideCarvedilol or Carvedilol/HCTZ

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or Female adults, 18 years or over
Essential Hypertension with mean SBP (systolic blood pressure) ≥ 140 mm Hg or mean DBP (diastolic blood pressure) ≥ 90 mm Hg* when blood pressure is measured at Visit 1(week -2) and at Visit 2(week 0).
If diabetes patients, mean SBP ≥ 130 mm Hg or mean DBP ≥ 80 mm Hg (Mean of blood pressure values measured consecutively at least 2 minutes apart)
Patient who is willing to, and is able to sign the informed consent form

Key exclusion criteria (5 listed)

Patient Is Pregnant Or Breastfeeding, Or Expecting To Conceive Within The Projected Duration Of The Study
Patient Has Known Or Suspected Secondary Hypertension Of Any Etiology
Patient has history of malignant hypertension
Patient has history of cerebrovascular accident (cerebral infarction) or myocardiac infarction within the last 6 months
Patient takes antihypertensive drugs

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
losartan potassiumOnce daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)	Drug	1
Comparator: carvedilolOnce daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)	Drug	2
Comparator: losartan (+) hydrochlorothiazide (HCTZ)Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg/ hydrochlorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)	Drug	1
Comparator: carvedilol (+) hydrochlorothiazideOnce daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)	Drug	2

Primary outcome

Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
Time frame: Baseline and 24 Weeks
Analysis was performed in the modified intention to treat (mITT) population.
PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
Time frame: Baseline and 24 Weeks
Analysis was performed in the per protocol (PP) population which additionally excludes certain protocol violations as described in the analysis plan.

2 secondary outcomes

Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
Time frame: Baseline and 24 weeks
Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
Time frame: Baseline and 24 weeks

Results and safety

Results posted to the registry on 15 Dec 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	101	83
Carvedilol	100	87

Primary outcome: Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug

Time frame: Baseline and 24 Weeks. Mean (Standard Deviation). Unit: meters/second

Measure	Losartan n = 88	Carvedilol n = 94
Value	0.28 (1.29)	-0.12 (1.55)

Losartan vs Carvedilol: Mean Difference (Final Values): -0.41 (95% CI -0.83 to 0.01)

Population analysed: Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94). Missing data were imputed by the last observation carried forward (LOCF) technique.

Primary outcome: PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug

Time frame: Baseline and 24 Weeks. Mean (Standard Deviation). Unit: meters/second

Measure	Losartan n = 54	Carvedilol n = 67
Value	0.16 (1.25)	-0.20 (1.50)

Losartan vs Carvedilol: Mean Difference (Final Values): -0.36 (95% CI -0.86 to 0.15)

Population analysed: Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). Missing data were imputed by the last observation carried forward (LOCF) technique. For the primary efficacy endpoints, Per protocol analysis approach was supplementary used.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded from first administration of study drug up to 14 days after the administration of final dose.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Losartan	5 of 101 (5%)	35 of 101 (34.7%)	Not reported
Carvedilol	6 of 100 (6%)	51 of 100 (51%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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 4 study testing losartan potassium, Comparator: carvedilol and Comparator: losartan (+) hydrochlorothiazide (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 4 inclusion and 5 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 22 May 2024. 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.

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?

Yes. Results are posted in the registry (first posted 15 Dec 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?

Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug (time frame: Baseline and 24 Weeks). The study lists 2 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 NCT00496834.

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 22 May 2024.