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A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00325962•BioMarin Pharmaceutical

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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.
+1 more criteria

Locations (24)

Hoover, Alabama, United States

Huntsville, Alabama, United States

Mobile, Alabama, United States

Muscle Shoals, Alabama, United States

Gilbert, Arizona, United States

Phoenix, Arizona, United States

Anaheim, California, United States

Burbank, California, United States

Cudahy, California, United States

Long Beach, California, United States

Key Dates

Start Date

May 1, 2006

Primary Completion Date

December 1, 2006

Completion Date

December 1, 2008

Last Updated

July 21, 2009

Enrollment

Estimated participants

Conditions

Hypertension

Interventions

6R-BH4 (sapropterin dihydrochloride)

DRUG

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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