HypertensionPhase 2NCT00325962
A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension
A Phase 2 study testing 6R-BH4 (sapropterin dihydrochloride) in people with Hypertension, run by BioMarin Pharmaceutical at 24 sites in United States.
Trial summary
The purpose of this study is to determine whether 6R-BH4 (sapropterin dihydrochloride) is safe and effective in the treatment of poorly controlled hypertension in the presence or absence of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- 6R-BH4 (sapropterin dihydrochloride)
- How many people
- 84 participants
- Where
- 24 sitesUnited States
- Study dates
- May 2006to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures.
- At least 18 years of age.
- Willing and able to comply with all study-related procedures.
- History of documented essential hypertension (BP greater than or equal to 140 mm Hg systolic and/or 90 mm Hg diastolic measured on 2 separate occasions).
- Have poorly controlled hypertension despite use of at least two conventional antihypertensive agents with different mechanisms of action taken concurrently and consistently for at least 3 months before randomization. (Note: Antihypertensive agents may be individual or combined into a single medication.)
- During the two-week screening period, mean SBP and mean DBP fall within the following ranges:
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- Mean SBP between 135 and 160 mm Hg
- Mean DBP between 85 and 110 mm Hg
- Sexually active subjects must be willing to use an acceptable method of contraception while participating in the study.
- Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during this study.
- Individuals in the diabetic cohort must meet this additional criterion:
- Documented history of type 2 diabetes that has been treated using the same therapy for at least 3 months.
Who cannot join
- Previous treatment with any formulation of BH4.
- Known allergy or hypersensitivity to any excipient of 6R-BH4.
- Known secondary cause for hypertension.
- Concurrent disease or condition that would interfere with study participation or safety such as bleeding disorders, history of syncope or vertigo, severe gastrointestinal reflux disease (GERD), symptomatic coronary or peripheral vascular disease, arrhythmia, organ transplant, organ failure, or type 1 diabetes mellitus.
- Any sever co-morbid condition that would limit life expectancy to less than 6 months.
- Serum creatinine >2.0mg/dL or hepatic enzyme levels more than 2 times the upper limit of normal.
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- Requirement for concomitant treatment with any drug known to inhibit folate metabolism (e.g., methotrexate).
- Concomitant treatment with levodopa.
- Concomitant treatment with any phosphodiesterase (PDE) 5 inhibitor (e.g., Viagra(R), Cialis(R), or Levitra(R), or Revatio (TM) or any PDE 3 inhibitor (e.g., cilostazol, milrinone, or vesnarinone).)
- Use of any investigational product or device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
- Pregnant or breastfeeding at screening or planning to become pregnant (subject or partner) at any time during study.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Study site
Anaheim, California
Study site
Atlanta, Georgia
Study site
Auburn, Maine
Study site
Baltimore, Maryland
Study site
Burbank, California
Study site
Carrollton, Texas
Study site
Charlotte, North Carolina
Study site
Cincinnati, Ohio
Study site
Cudahy, California
Study site
Decatur, Georgia
Study site
Denver, Colorado
Study site
Gilbert, Arizona
Study site
Hoover, Alabama
Study site
Huntsville, Alabama
Study site
Indianapolis, Indiana
Study site
Knoxville, Tennessee
Study site
Long Beach, California
Study site
Mobile, Alabama
Study site
Muscle Shoals, Alabama
Study site
Pembroke Pines, Florida
Study site
Phoenix, Arizona
Study site
Roseville, California
Study site
San Francisco, California
Study site
Scarborough, Maine
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension
The purpose of this study is to determine whether 6R-BH4 (sapropterin dihydrochloride) is safe and effective in the treatment of poorly controlled hypertension in the presence or absence of type 2 diabetes.
- Conditions
- Hypertension
- Being tested
- 6R-BH4 (sapropterin dihydrochloride)
- Keywords
- Hypertension, Type 2 Diabetes, 6R-BH4, BH4, BH4 deficiency, sapropterin dihydrochloride, endothelial dysfunction, NO, Nitric Oxide
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Phenylketonurias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6R-BH4 (sapropterin dihydrochloride)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare oral 6R-BH4 to placebo with respect to change from baseline in arterial systolic blood pressure after 8 weeks of treatment in subjects with poorly controlled hypertension.
Secondary outcomes (4)
To compare oral 6R-BH4 to placebo with respect to change from baseline in arterial diastolic blood pressure after 8 weeks of treatment in subjects with poorly controlled hypertension
To compare oral 6R-BH4 to placebo with respect to change from baseline in insulin sensitivity after 8 weeks of treatment in subjects with both type 2 diabetes and poorly controlled hypertension
To compare oral 6R-BH4 to placebo with respect to change from baseline in eNOS activity and endothelial dysfunction after 8 weeks of treatment in subjects with poorly controlled hypertension
To assess the safety of oral dosing of 6R-BH4 in subjects with poorly controlled hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2006
- Study completionDec 2008
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 BioMarin PharmaceuticalThe 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
- Enrolment
- 84 participants
Sponsor and investigators
- Lead sponsor
- BioMarin Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martha Nicholson, MD, Study director, BioMarin Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325962
- Sponsor's protocol ID
- HTN-001
- Status last verified
- Jul 2009
- First submitted
- 11 May 2006
- Last updated
- 21 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension
- ClinicalTrials.gov ID
- NCT00325962
- Acronym / sponsor ID
- HTN-001
- Conditions
- Hypertension
- Keywords
- Hypertension, Type 2 Diabetes, 6R-BH4, BH4, BH4 deficiency, sapropterin dihydrochloride, endothelial dysfunction, NO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants
- Lead sponsor
- BioMarin PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 15 May 2006 (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 determine whether 6R-BH4 (sapropterin dihydrochloride) is safe and effective in the treatment of poorly controlled hypertension in the presence or absence of type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures.
- At least 18 years of age.
- Willing and able to comply with all study-related procedures.
- History of documented essential hypertension (BP greater than or equal to 140 mm Hg systolic and/or 90 mm Hg diastolic measured on 2 separate occasions).
- Have poorly controlled hypertension despite use of at least two conventional antihypertensive agents with different mechanisms of action taken concurrently and consistently for at least 3 months before randomization. (Note: Antihypertensive agents may be individual or combined into a single medication.)
Key exclusion criteria (11 listed)
- Previous treatment with any formulation of BH4.
- Known allergy or hypersensitivity to any excipient of 6R-BH4.
- Known secondary cause for hypertension.
- Concurrent disease or condition that would interfere with study participation or safety such as bleeding disorders, history of syncope or vertigo, severe gastrointestinal reflux disease (GERD), symptomatic coronary or peripheral vascular disease, arrhythmia, organ transplant, organ failure, or type 1 diabetes mellitus.
- Any sever co-morbid condition that would limit life expectancy to less than 6 months.
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 |
|---|---|---|
| 6R-BH4 (sapropterin dihydrochloride) | Drug | – |
Primary outcome
To compare oral 6R-BH4 to placebo with respect to change from baseline in arterial systolic blood pressure after 8 weeks of treatment in subjects with poorly controlled hypertension.
4 secondary outcomes
To compare oral 6R-BH4 to placebo with respect to change from baseline in arterial diastolic blood pressure after 8 weeks of treatment in subjects with poorly controlled hypertension
To compare oral 6R-BH4 to placebo with respect to change from baseline in insulin sensitivity after 8 weeks of treatment in subjects with both type 2 diabetes and poorly controlled hypertension
To compare oral 6R-BH4 to placebo with respect to change from baseline in eNOS activity and endothelial dysfunction after 8 weeks of treatment in subjects with poorly controlled hypertension
To assess the safety of oral dosing of 6R-BH4 in subjects with poorly controlled hypertension
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 21 Jul 2009.
- BioMarin Pharmaceutical Inc. websiteLink provided by the sponsor.
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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.
Martha Nicholson, MD study director
BioMarin Pharmaceutical
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 6R-BH4 (sapropterin dihydrochloride) in people with Hypertension, run by BioMarin Pharmaceutical at 24 sites 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 12 inclusion and 11 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 21 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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.
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 compare oral 6R-BH4 to placebo with respect to change from baseline in arterial systolic blood pressure after 8 weeks of treatment in subjects with poorly controlled hypertension.. 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 21 Jul 2009.