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

July 17, 2009 updated by: BioMarin Pharmaceutical

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hoover, Alabama, United States
      • Huntsville, Alabama, United States
      • Mobile, Alabama, United States
      • Muscle Shoals, Alabama, United States
    • Arizona
      • Gilbert, Arizona, United States
      • Phoenix, Arizona, 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
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Pembroke Pines, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Decatur, Georgia, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Maine
      • Auburn, Maine, United States
      • Scarborough, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Tennessee
      • Knoxville, Tennessee, United States
    • Texas
      • Carrollton, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioMarin Pharmaceutical

Investigators

  • Study Director: Martha Nicholson, MD, BioMarin Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

May 11, 2006

First Submitted That Met QC Criteria

May 11, 2006

First Posted (ESTIMATE)

May 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2009

Last Update Submitted That Met QC Criteria

July 17, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTN-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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