HypertensionPhase 2NCT00274716

Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)

A Phase 2 study testing MK0736 and MK0916 in people with Hypertension, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

The objective of this study is to evaluate the safety and efficacy of two investigational drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with hypertension (high blood pressure). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hypertension
What is being tested?: MK0736 and MK0916
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 249 participants
Where: No sites listed yet
Study dates: Nov 2005to Jan 2007
Phase: Phase 2
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Hypertension systolic blood pressure (SBP) </= 160mm Hg and diastolic blood pressure (DBP): 90-105mm Hg

Who cannot join

Pre-menopausal women
patients currently taking more than two (2) blood pressure lowering medications
Body Mas Index (BMI)>40 kg/m2 (morbidly obese patients)
History of Alcohol abuse (<3 Years)
History of diabetes,chronic kidney disease, Active liver disease, recent heart attack or stroke

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of MK0736 and MK0916 in Hypertensive Patients

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Read the detailed description

Participants enrolled in the study will be separated into 2 strata based on baseline body mass index (BMI) assessments prior to being randomly assigned to study treatment. Study will include a 24-week treatment period comprised of 2 phases, A and B, each of which will 12 weeks in duration.

Conditions: Hypertension
Being tested: MK0736, MK0916, Placebo
Medical subject headings: Hypertension

What participants receive

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

MK0736Drug
MK0916Drug
PlaceboDrug

Study groups in NCT00274716
Study group	Role	What they receive
High BMI:MK-0736 2mg→Placebo	Experimental	Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) Receives: Drug: MK0736; Drug: Placebo
High BMI:MK-0736 7mg→Placebo	Experimental	Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) Receives: Drug: MK0736; Drug: Placebo
High BMI:MK-0916 6mg→MK-0916 6mg	Experimental	Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) Receives: Drug: MK0916
High BMI:Placebo→Placebo	Placebo comparator	Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) Receives: Drug: Placebo
Low BMI:MK-0916 6mg→MK-0916 6mg	Experimental	Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) Receives: Drug: MK0916
Low BMI:Placebo→Placebo	Placebo comparator	Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.
Measured: Baseline and Week 12 (end of Phase A)
Number of Participants Who Reported a Clinical Adverse Event
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.
Measured: 24 weeks
Number of Participants Who Reported a Laboratory Adverse Event
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.
Measured: 24 weeks
Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.
Measured: 24 weeks
Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.
Measured: 24 weeks

Secondary outcomes (6)

Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded.
Measured: Baseline and Week 12 (end of Phase A)
Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI
Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis.
Measured: Baseline and Week 12 (end of Phase A)
Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI
Waist circumference measured in cm at baseline and after 12 weeks of study drug administration
Measured: Baseline and Week 12 (end of Phase A)
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)
LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration.
Measured: Baseline and Week 12 (end of Phase A)
Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI
HDL-C measured at baseline and after 12 weeks of study drug administration.
Measured: Baseline and Week 12 (end of Phase A)
Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)
TG measured at baseline and after 12 weeks of study drug administration
Measured: Baseline and Week 12 (end of Phase A)

Timeline

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

Nov 2005Jan 2007

First posted11 Jan 2006 (estimated)
Study startNov 2005
Primary completionJan 2007
Study completionJan 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.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 249 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00274716
Sponsor's protocol ID: 0736-003
Other IDs: 2006_004
Status last verified: Jun 2015
First submitted: 10 Jan 2006
Last updated: 3 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Shah S, Hermanowski-Vosatka A, Gibson K, Ruck RA, Jia G, Zhang J, Hwang PM, Ryan NW, Langdon RB, Feig PU. Efficacy and safety of the selective 11beta-HSD-1 inhibitors MK-0736 and MK-0916 in overweight and obese patients with hypertension. J Am Soc Hypertens. 2011 May-Jun;5(3):166-76. doi: 10.1016/j.jash.2011.01.009. Epub 2011 Mar 21.
PubMed 21419745

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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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Recruiting
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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

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of MK0736 and MK0916 in Hypertensive Patients
ClinicalTrials.gov ID: NCT00274716
Acronym / sponsor ID: 0736-003
Conditions: Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 249 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2005
Primary completion: Jan 2007 (actual)
Study completion: Jan 2007 (actual)
First posted: 11 Jan 2006 (estimated)
Results: Posted 14 Feb 2014

Clinical summary

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

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
High BMI:MK-0736 2mg→Placebo	Experimental	Drug: MK0736, Drug: PlaceboParticipants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
High BMI:MK-0736 7mg→Placebo	Experimental	Drug: MK0736, Drug: PlaceboParticipants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
High BMI:MK-0916 6mg→MK-0916 6mg	Experimental	Drug: MK0916Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
High BMI:Placebo→Placebo	Placebo comparator	Drug: PlaceboParticipants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Low BMI:MK-0916 6mg→MK-0916 6mg	Experimental	Drug: MK0916Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
Low BMI:Placebo→Placebo	Placebo comparator	Drug: PlaceboParticipants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Hypertension systolic blood pressure (SBP) </= 160mm Hg and diastolic blood pressure (DBP): 90-105mm Hg

Key exclusion criteria (5 listed)

Pre-menopausal women
patients currently taking more than two (2) blood pressure lowering medications
Body Mas Index (BMI)>40 kg/m2 (morbidly obese patients)
History of Alcohol abuse (<3 Years)
History of diabetes,chronic kidney disease, Active liver disease, recent heart attack or stroke

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
MK0736	Drug	High BMI:MK-0736 2mg→Placebo, High BMI:MK-0736 7mg→Placebo
MK0916	Drug	High BMI:MK-0916 6mg→MK-0916 6mg, Low BMI:MK-0916 6mg→MK-0916 6mg
Placebo	Drug	High BMI:MK-0736 2mg→Placebo, High BMI:MK-0736 7mg→Placebo, High BMI:Placebo→Placebo, Low BMI:Placebo→Placebo

Primary outcome

Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Time frame: Baseline and Week 12 (end of Phase A)
Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.
Number of Participants Who Reported a Clinical Adverse Event
Time frame: 24 weeks
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.
Number of Participants Who Reported a Laboratory Adverse Event
Time frame: 24 weeks
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.
Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event
Time frame: 24 weeks
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.
Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event
Time frame: 24 weeks
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.

6 secondary outcomes

Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Time frame: Baseline and Week 12 (end of Phase A)
Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI
Time frame: Baseline and Week 12 (end of Phase A)
Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI
Time frame: Baseline and Week 12 (end of Phase A)
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Time frame: Baseline and Week 12 (end of Phase A)
Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI
Time frame: Baseline and Week 12 (end of Phase A)
Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Time frame: Baseline and Week 12 (end of Phase A)

Results and safety

Results posted to the registry on 14 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High BMI:MK-0736 2mg→Placebo	54	43
High BMI:MK-0736 7mg→Placebo	54	44
High BMI:MK-0916 6mg→MK-0916 6mg	52	44
High BMI:Placebo→Placebo	51	42
Low BMI:MK-0916 6mg→MK-0916 6mg	19	16
Low BMI:Placebo→Placebo	19	15

Primary outcome: Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)

Time frame: Baseline and Week 12 (end of Phase A). Mean (Standard Deviation). Unit: mm Hg

Measure	MK-0736 2.0 mg High BMI n = 53	MK-0736 7.0 mg High BMI n = 52	MK-0916 6.0 mg High BMI n = 49	Placebo High BMI n = 51
Value	-4.2 (7.3)	-2.4 (8.1)	-3.1 (7.9)	-0.2 (8.7)

MK-0736 7.0 mg High BMI vs Placebo High BMI: Mean Difference (Final Values): -2.2 (95% CI -5.3 to 0.9), p = 0.157, ANCOVA
MK-0736 2.0 mg High BMI vs Placebo High BMI: Mean Difference (Final Values): -4.1 (95% CI -7.1 to -1.0), p = 0.010, ANCOVA
MK-0916 6.0 mg High BMI vs Placebo High BMI: Mean Difference (Final Values): -3.2 (95% CI -6.4 to -0.1), p = 0.042, ANCOVA

Population analysed: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.

Primary outcome: Number of Participants Who Reported a Clinical Adverse Event

Time frame: 24 weeks. Number. Unit: Participants

Measure	High BMI:MK-0736 2mg→Placebo n = 54	High BMI:MK-0736 7mg→Placebo n = 54	High BMI:MK-0916 6mg→MK-0916 6mg n = 52	High BMI:Placebo→Placebo n = 51	Low BMI:MK-0916 6mg→MK-0916 6mg n = 19	Low BMI:Placebo→Placebo n = 19
Value	44	39	38	36	16	11

Population analysed: All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.

Primary outcome: Number of Participants Who Reported a Laboratory Adverse Event

Time frame: 24 weeks. Number. Unit: Participants

Measure	High BMI:MK-0736 2mg→Placebo n = 54	High BMI:MK-0736 7mg→Placebo n = 54	High BMI:MK-0916 6mg→MK-0916 6mg n = 52	High BMI:Placebo→Placebo n = 51	Low BMI:MK-0916 6mg→MK-0916 6mg n = 19	Low BMI:Placebo→Placebo n = 19
Value	1	2	0	2	0	0

Population analysed: All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.

Primary outcome: Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event

Time frame: 24 weeks. Number. Unit: Participants

Measure	High BMI:MK-0736 2mg→Placebo n = 54	High BMI:MK-0736 7mg→Placebo n = 54	High BMI:MK-0916 6mg→MK-0916 6mg n = 52	High BMI:Placebo→Placebo n = 51	Low BMI:MK-0916 6mg→MK-0916 6mg n = 19	Low BMI:Placebo→Placebo n = 19
Value	2	3	6	0	2	1

Population analysed: All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High BMI:MK-0736 2mg→Placebo	2 of 54 (3.7%)	40 of 54 (74.1%)	Not reported
High BMI:MK-0736 7mg→Placebo	1 of 54 (1.9%)	39 of 54 (72.2%)	Not reported
High BMI:MK-0916 6mg→MK-0916 6mg	2 of 52 (3.8%)	37 of 52 (71.2%)	Not reported
High BMI:Placebo→Placebo	1 of 51 (2%)	37 of 51 (72.5%)	Not reported
Low BMI:MK-0916 6mg→MK-0916 6mg	2 of 19 (10.5%)	16 of 19 (84.2%)	Not reported
Low BMI:Placebo→Placebo	1 of 19 (5.3%)	11 of 19 (57.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21419745Shah S, Hermanowski-Vosatka A, Gibson K, Ruck RA, Jia G, Zhang J, Hwang PM, Ryan NW, Langdon RB, Feig PU. Efficacy and safety of the selective 11beta-HSD-1 inhibitors MK-0736 and MK-0916 in overweight and obese patients with hypertension. J Am Soc Hypertens. 2011 May-Jun;5(3):166-76. doi: 10.1016/j.jash.2011.01.009. Epub 2011 Mar 21.

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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 2 study testing MK0736 and MK0916 in people with Hypertension, run by Merck Sharp & Dohme LLC.

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 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 3 Jul 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 Feb 2014). 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?

Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) (time frame: Baseline and Week 12 (end of Phase A)). The study lists 5 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 NCT00274716, 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 3 Jul 2015.