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

• ClinicalTrials.gov Identifier: NCT00272961
• Recruitment Status: Terminated
• First Posted: January 9, 2006
• Results First Posted: March 5, 2013
• Last Update Posted: March 5, 2013
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Resistant Hypertension	Drug: Placebo; Drug: TBC3711	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: January 2006
• Actual Primary Completion Date: August 2008
• Actual Study Completion Date: August 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Maximum Blood Pressure (BP) Increase [ Time Frame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12 ]
   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.
2. 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 ]
   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 :

1. 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 ]
   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.
2. 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 ]
   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.
3. 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 ]
   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.
4. 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 ]
   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.
5. Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 [ Time Frame: Pre-Dose and 2 hours Post-Dose on Week 10 ]
   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.
6. Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 [ Time Frame: Pre-Dose and 2 hours Post-Dose on Week 10 ]
   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.
7. 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 ]
   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.
8. 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00272961
• Other Study ID Numbers: B1341001; GRH01
• First Posted: January 9, 2006
• Results First Posted: March 5, 2013
• Last Update Posted: March 5, 2013
• Last Verified: January 2013

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; N-(2-acetyl-4,6-dimethylphenyl)-3-(3,4-dimethylisoxazol-5-ylsulfamoyl)thiophene-2-carboxamide; Endothelin A Receptor Antagonists; Endothelin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action