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A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.

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NCT00272961

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294-2041 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Resistant Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of resistant hypertension.

- A stable anti-hypertensive drug regimen for at least 30 days.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Sustained blood pressure greater than or equal to 180/120 mmHg.

- Required use of thigh cuff for blood pressure readings.

- Uncontrolled diabetes mellitus.

NCT00272961
Pfizer
Terminated
A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.

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A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.
A Phase 2 Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Ranging Study Of TBC3711 In Subjects With Resistant Hypertension
The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.
The study was stopped due to Pfizer (sponsor) decision that the compound would not be involved in any further clinical development for the indication of resistant hypertension on 05 August 2008. This decision was not based on any safety or efficacy concern.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Resistant Hypertension
  • Drug: Placebo
    placebo tablet once daily for 12 weeks
  • Drug: TBC3711
    10 mg tablets once daily for 10 weeks
  • Drug: TBC3711
    50 mg tablet once daily for 10 weeks
  • Drug: TBC3711
    100 mg tablet once daily for 10 weeks
  • Drug: TBC3711
    200 mg tablet once daily for 10 weeks
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
  • Experimental: ARM 1
    Intervention: Drug: TBC3711
  • Experimental: ARM 2
    Intervention: Drug: TBC3711
  • Experimental: ARM 3
    Intervention: Drug: TBC3711
  • Experimental: ARM 4
    Intervention: Drug: TBC3711
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
August 2008
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of resistant hypertension.
  • A stable anti-hypertensive drug regimen for at least 30 days.

Exclusion Criteria:

  • Sustained blood pressure greater than or equal to 180/120 mmHg.
  • Required use of thigh cuff for blood pressure readings.
  • Uncontrolled diabetes mellitus.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00272961
B1341001
GRH01
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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