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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00272961
First received: January 4, 2006
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Resistant Hypertension
Drug: Placebo
Drug: TBC3711
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Ranging Study Of TBC3711 In Subjects With Resistant Hypertension

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum Blood Pressure (BP) Increase [ Time Frame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12 ] [ Designated as safety issue: Yes ]
    BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values.

  • Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change [ Time Frame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12 ] [ Designated as safety issue: Yes ]
    AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account.


Secondary Outcome Measures:
  • Sitting Systolic Blood Pressure (SBP) [ Time Frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 ] [ Designated as safety issue: Yes ]
    SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80 percent [%] of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.

  • Standing Systolic Blood Pressure (SBP) [ Time Frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 ] [ Designated as safety issue: Yes ]
    SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.

  • Sitting Diastolic Blood Pressure (DBP) [ Time Frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 ] [ Designated as safety issue: Yes ]
    DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.

  • Standing Diastolic Blood Pressure (DBP) [ Time Frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 ] [ Designated as safety issue: Yes ]
    DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.

  • Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 [ Time Frame: Pre-Dose and 2 hours Post-Dose on Week 10 ] [ Designated as safety issue: Yes ]
    SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.

  • Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 [ Time Frame: Pre-Dose and 2 hours Post-Dose on Week 10 ] [ Designated as safety issue: Yes ]
    DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.

  • Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 [ Time Frame: Pre-Dose and 2 hours Post-Dose on Week 10 ] [ Designated as safety issue: Yes ]
    SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.

  • Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 [ Time Frame: Pre-Dose and 2 hours Post-Dose on Week 10 ] [ Designated as safety issue: Yes ]
    DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.


Enrollment: 60
Study Start Date: January 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: Placebo
placebo tablet once daily for 12 weeks
Experimental: ARM 1 Drug: TBC3711
10 mg tablets once daily for 10 weeks
Experimental: ARM 2 Drug: TBC3711
50 mg tablet once daily for 10 weeks
Experimental: ARM 3 Drug: TBC3711
100 mg tablet once daily for 10 weeks
Experimental: ARM 4 Drug: TBC3711
200 mg tablet once daily for 10 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272961

Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-2041
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30309
Pfizer Investigational Site
Augusta, Georgia, United States, 30904
United States, Louisiana
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71101
United States, New York
Pfizer Investigational Site
Albany, New York, United States, 12206
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73132-4904
United States, South Carolina
Pfizer Investigational Site
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Pfizer Investigational Site
Germantown, Tennessee, United States, 38138
United States, Texas
Pfizer Investigational Site
Carroltown, Texas, United States, 75006
Pfizer Investigational Site
Dallas, Texas, United States, 75235
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98133
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00272961     History of Changes
Other Study ID Numbers: B1341001, GRH01
Study First Received: January 4, 2006
Results First Received: January 28, 2013
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014