HypertensionPhase 2NCT00543413
A Study to Determine the Effectiveness and Tolerability of MK8141 in Patients With High Blood Pressure (MK-8141-006)
A Phase 2 study testing MK8141 and Enalapril in people with Hypertension, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the effectiveness and tolerability of MK8141 in lowering blood pressure in patients who have hypertension (high blood pressure). Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- MK8141 and Enalapril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Jun 2008
- Phase
- Phase 2
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You are 35 to 65 years of age
- In the past 14 days you have not been treated for hypertension
- In the past 14 days you have not taken more than 2 medications to treat high blood pressure
- You are a woman who is not able to have children or do not use birth control
Who cannot join
- You are taking more than 2 medications to treat high blood pressure
- You have a history of a stroke, transient ischemic attack (TIA), heart attack, congestive heart failure, coronary artery bypass surgery
- You have Type 1 or 2 diabetes mellitus
- You have an active liver disease, gallbladder disease, or bowel disease
- You are HIV positive
- You have certain types of cancer
- You abuse drug or alcohol
- You have participated in another clinical study in last 4 weeks
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Assess the Efficacy and Tolerability of MK8141 in Hypertensive Patients
This study will evaluate the effectiveness and tolerability of MK8141 in lowering blood pressure in patients who have hypertension (high blood pressure).
- Conditions
- Hypertension
- Being tested
- MK8141, Comparator: placebo (unspecified), Enalapril
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK8141Drug
MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period
Comparator: placebo (unspecified)Drug
MK8141 Pbo tablet once daily. 4 week treatment period.
EnalaprilDrug
Also called Vasotec®
Enalapril 20 mg tablet once daily. 4 week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arm 1: Drug 250 mg Receives: Drug: MK8141 |
| 2 | Experimental | Arm 2: Drug 500 mg Receives: Drug: MK8141 |
| 3 | Active comparator | Arm 3: Active Comparator Receives: Drug: Enalapril |
| 4 | Placebo comparator | Arm 4: Pbo Comparator Receives: Drug: Comparator: placebo (unspecified) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment.
Measured: after 4 weeks of treatment
Secondary outcomes (1)
Compare MK8141 versus placebo in lowering 24-hour mean sitting blood pressure by ambulatory blood pressure monitoring and in lowering trough mean sitting diastolic and systolic blood pressure after 4 weeks of treatment.
Measured: after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Actelion
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543413
- Sponsor's protocol ID
- 8141-006
- Other IDs
- MK8141-006, 2007_587
- Status last verified
- Oct 2015
- First submitted
- 5 Oct 2007
- Last updated
- 16 Oct 2015
- Results posted
- No
Publications
Jones-Burton C, Rubino J, Roy S, Mai Y, Meehan A, Bellet M, Feig P. Effects of the renin inhibitor MK-8141 (ACT-077825) in patients with hypertension. J Am Soc Hypertens. 2010 Sep-Oct;4(5):219-26. doi: 10.1016/j.jash.2010.06.006. Epub 2010 Aug 12.
PubMed 20705534
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Assess the Efficacy and Tolerability of MK8141 in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00543413
- Acronym / sponsor ID
- 8141-006
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Actelion
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 Oct 2007 (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.
This study will evaluate the effectiveness and tolerability of MK8141 in lowering blood pressure in patients who have hypertension (high blood pressure).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MK8141Arm 1: Drug 250 mg |
| 2 | Experimental | Drug: MK8141Arm 2: Drug 500 mg |
| 3 | Active comparator | Drug: EnalaprilArm 3: Active Comparator |
| 4 | Placebo comparator | Drug: Comparator: placebo (unspecified)Arm 4: Pbo Comparator |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- You are 35 to 65 years of age
- In the past 14 days you have not been treated for hypertension
- In the past 14 days you have not taken more than 2 medications to treat high blood pressure
- You are a woman who is not able to have children or do not use birth control
Key exclusion criteria (8 listed)
- You are taking more than 2 medications to treat high blood pressure
- You have a history of a stroke, transient ischemic attack (TIA), heart attack, congestive heart failure, coronary artery bypass surgery
- You have Type 1 or 2 diabetes mellitus
- You have an active liver disease, gallbladder disease, or bowel disease
- You are HIV positive
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 |
|---|---|---|
| MK8141MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period | Drug | 1, 2 |
| Comparator: placebo (unspecified)MK8141 Pbo tablet once daily. 4 week treatment period. | Drug | 4 |
| EnalaprilAlso: Vasotec®Enalapril 20 mg tablet once daily. 4 week treatment period. | Drug | 3 |
Primary outcome
To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment.
Time frame: after 4 weeks of treatment
1 secondary outcome
Compare MK8141 versus placebo in lowering 24-hour mean sitting blood pressure by ambulatory blood pressure monitoring and in lowering trough mean sitting diastolic and systolic blood pressure after 4 weeks of treatment.
Time frame: after 4 weeks of treatment
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 16 Oct 2015.
- Results publication: PubMed 20705534Jones-Burton C, Rubino J, Roy S, Mai Y, Meehan A, Bellet M, Feig P. Effects of the renin inhibitor MK-8141 (ACT-077825) in patients with hypertension. J Am Soc Hypertens. 2010 Sep-Oct;4(5):219-26. doi: 10.1016/j.jash.2010.06.006. Epub 2010 Aug 12.
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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK8141 and Enalapril 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 4 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 16 Oct 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?
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?
To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment. (time frame: after 4 weeks of treatment). 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 NCT00543413, 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 16 Oct 2015.