Safety and Effect of Oral Doses of 5mg or 10mg of SLx-2101 for 14 Days 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

NCT00562614

SLx-2101-07-08

Details and patient eligibility

About

The purpose is to determine the effect of SLx-2101 dosed at 5mg or 10mg for 14 days on systolic, diastolic pressures and heart rate in patients with hypertension.

Full description

1. Placebo-corrected supine peripheral systolic, diastolic blood pressures and heart rate
2. 24 hour ambulatory blood pressure and heart rate
3. Safety and tolerability

Enrollment: 38 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects between 18 and 70 years old, inclusive
• Moderate to severe hypertension
• Body weight within a body mass index of 18-32kg/m2

Exclusion criteria

• The subject is receiving more than three antihypertensive agents
• A 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

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38 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

SLx-2101

Treatment:

Drug: SLx-2101

2

Placebo Comparator group

Description:

Comparative Placebo Dose

Treatment:

Drug: SLx-2101