HypertensionNCT01009944
Genetic Mechanisms in Human Hypertension Renin-angiotensin-aldosterone System (RAAS) Inhibition Study
A study testing Lisinopril, Atenolol in people with Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to develop an approach to provide personalized medicine to individuals who have hypertension (high blood pressure). The investigators plan to use people's genetic characteristics (traits) to determine what medication they should use to lower their blood pressure most effectively. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Lisinopril, Atenolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to 19 Mar 2019
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female hypertensive participants who were previously studied in SCOR program.
Who cannot join
- Diabetes
- Taking other medications beside thyroid or estrogen supplements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Genetic Mechanisms in Human Hypertension RAAS Inhibition Study
The purpose of this study is to develop an approach to provide personalized medicine to individuals who have hypertension (high blood pressure). The investigators plan to use people's genetic characteristics (traits) to determine what medication they should use to lower their blood pressure most effectively. The investigators will give individuals one of two medications to treat hypertension (lisinopril or atenolol). The investigators believe that depending on the individuals genetic background one medication will work better in lowering their blood pressure.
- Conditions
- Hypertension
- Being tested
- Lisinopril, Atenolol
- Keywords
- High blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lisinopril, AtenololDrug
Also called Tenormin (Atenolol), Prinivil, Zestril (Lisinopril)
once a day for 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lisinopril, Atenolol | Experimental | Not described Receives: Drug: Lisinopril, Atenolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
One type of blood pressure medication will better treat individuals with certain genetic backgrounds.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startJan 2007
- Primary completion19 Mar 2019
- Study completion19 Mar 2019
Why it stopped: Not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Principal investigator, Gordon H. Williams, MD, Brigham and Women's Hospital
- Investigators
- Gordon H. Williams, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009944
- Sponsor's protocol ID
- 2007p002290
- Status last verified
- Apr 2021
- First submitted
- 6 Nov 2009
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Mechanisms in Human Hypertension RAAS Inhibition Study
- ClinicalTrials.gov ID
- NCT01009944
- Acronym / sponsor ID
- 2007p002290
- Conditions
- Hypertension
- Keywords
- High blood pressure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- University of Utah
- Study start
- Jan 2007 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 9 Nov 2009 (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.
The purpose of this study is to develop an approach to provide personalized medicine to individuals who have hypertension (high blood pressure). The investigators plan to use people's genetic characteristics (traits) to determine what medication they should use to lower their blood pressure most effectively. The investigators will give individuals one of two medications to treat hypertension (lisinopril or atenolol). The investigators believe that depending on the individuals genetic background one medication will work better in lowering their blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lisinopril, Atenolol | Experimental | Drug: Lisinopril, Atenolol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female hypertensive participants who were previously studied in SCOR program.
Key exclusion criteria (2 listed)
- Diabetes
- Taking other medications beside thyroid or estrogen supplements.
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 |
|---|---|---|
| Lisinopril, AtenololAlso: Tenormin (Atenolol), Prinivil, Zestril (Lisinopril)once a day for 14 weeks | Drug | Lisinopril, Atenolol |
Primary outcome
One type of blood pressure medication will better treat individuals with certain genetic backgrounds.
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
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.
Gordon H. Williams, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lisinopril, Atenolol in people with Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
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 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: withdrawn, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
One type of blood pressure medication will better treat individuals with certain genetic backgrounds. (time frame: 16 weeks). 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 Apr 2021.