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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Resistant Hypertension

Treatments: Drug: TBC3711; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00272961

B1341001

GRH01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 5 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Drug: Placebo

ARM 1

Experimental group

Treatment:

Drug: TBC3711

Drug: TBC3711

Drug: TBC3711

Drug: TBC3711

ARM 2

Experimental group

Treatment:

Drug: TBC3711

Drug: TBC3711

Drug: TBC3711

Drug: TBC3711

ARM 3

Experimental group

Treatment:

Drug: TBC3711

Drug: TBC3711

Drug: TBC3711

Drug: TBC3711

ARM 4

Experimental group

Treatment:

Drug: TBC3711

Drug: TBC3711

Drug: TBC3711

Drug: TBC3711