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A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00325962
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : July 21, 2009
Sponsor:
Information provided by:
BioMarin Pharmaceutical

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: 6R-BH4 (sapropterin dihydrochloride) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : May 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2008

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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
  2. 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
  3. 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
  4. To assess the safety of oral dosing of 6R-BH4 in subjects with poorly controlled hypertension

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325962


Locations
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United States, Alabama
Hoover, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Muscle Shoals, Alabama, United States
United States, Arizona
Gilbert, Arizona, United States
Phoenix, Arizona, United States
United States, California
Anaheim, California, United States
Burbank, California, United States
Cudahy, California, United States
Long Beach, California, United States
Roseville, California, United States
San Francisco, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Florida
Pembroke Pines, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Decatur, Georgia, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Maine
Auburn, Maine, United States
Scarborough, Maine, United States
United States, Maryland
Baltimore, Maryland, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Tennessee
Knoxville, Tennessee, United States
United States, Texas
Carrollton, Texas, United States
Sponsors and Collaborators
BioMarin Pharmaceutical
Investigators
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Study Director: Martha Nicholson, MD BioMarin Pharmaceutical
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00325962    
Other Study ID Numbers: HTN-001
First Posted: May 15, 2006    Key Record Dates
Last Update Posted: July 21, 2009
Last Verified: July 2009
Keywords provided by BioMarin Pharmaceutical:
Hypertension
Type 2 Diabetes
6R-BH4
BH4
BH4 deficiency
 sapropterin dihydrochloride
endothelial dysfunction
NO
Nitric Oxide
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Verapamil
Anti-Arrhythmia Agents
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents