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

Resistant Hypertension Clinical Trial

Official title:

A Phase 2 Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Ranging Study Of TBC3711 In Subjects With Resistant Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00272961
• Other study ID #: B1341001
• Secondary ID: GRH01
• Status: Terminated
• Phase: Phase 2
• First received: January 4, 2006
• Last updated: January 28, 2013
• Start date: January 2006
• Est. completion date: August 2008

Study information

• Verified date: January 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Intervention

Drug:
• Placebo
placebo tablet once daily for 12 weeks
• TBC3711
10 mg tablets once daily for 10 weeks
• TBC3711
50 mg tablet once daily for 10 weeks
• TBC3711
100 mg tablet once daily for 10 weeks
• TBC3711
200 mg tablet once daily for 10 weeks

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Albany	New York
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Augusta	Georgia
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Carroltown	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Germantown	Tennessee
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Simpsonville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Blood Pressure (BP) Increase	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.	Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12	Yes
Primary	Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change	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.	Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12	Yes
Secondary	Sitting Systolic Blood Pressure (SBP)	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.	Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10	Yes
Secondary	Standing Systolic Blood Pressure (SBP)	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.	Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10	Yes
Secondary	Sitting Diastolic Blood Pressure (DBP)	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.	Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10	Yes
Secondary	Standing Diastolic Blood Pressure (DBP)	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.	Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10	Yes
Secondary	Change From Standing to Sitting Systolic Blood Pressure (SBP) at 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.	Pre-Dose and 2 hours Post-Dose on Week 10	Yes
Secondary	Change From Standing to Sitting Diastolic Blood Pressure (DBP) at 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.	Pre-Dose and 2 hours Post-Dose on Week 10	Yes
Secondary	Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at 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.	Pre-Dose and 2 hours Post-Dose on Week 10	Yes
Secondary	Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at 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.	Pre-Dose and 2 hours Post-Dose on Week 10	Yes

External Links

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