Safety and Effects of SLx-2101 Taken for up to 14 Days on Blood Pressure in Patients With Hypertension

Response Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: SLx-2101

Study type: Interventional

Funder types: Industry

Identifiers

NCT00562549

SLx-2101-07-05

Details and patient eligibility

About

The purpose is to determine the effective dosage and to study the effects of this dosage taken for 12 days on systolic and diastolic blood pressure in patients with hypertension.

Full description

1. Office seated peripheral systolic and diastolic blood pressure
2. Adverse events and vital signs
3. Plasma concentrations of SLx-2101

Enrollment: 26 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or females between 18 and 80 years, inclusive
• Moderate to severe hypertension
• Body weight within a body mass index range of 18 - 32 kg/m2

Exclusion criteria

• Subject is receiving more than four antihypertensive agents
• History of drug abuse
• Exposure to a new chemical entity within 3 months prior to the first day of dosing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

26 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

SLx-2101

Treatment:

Drug: SLx-2101

2

Placebo Comparator group

Description:

Matching Placebo Dose

Treatment:

Drug: SLx-2101