Effects Of An Oral Growth Hormone Secretagogue In Older Functionally Limited Adults

Phase 2TerminatedNCT00527046

Pfizer396 enrolled

Overview

A 24-month, placebo controlled, double dummy, parallel-design outpatient trial in generally healthy elderly men and women who are at risk of becoming frail.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

396

Conditions

Aging Frail Older Adults

Interventions

CP-424,391DRUG

Eligibility

Sex: ALLMin age: 65 YearsMax age: 84 Years

Medical Language ↔ Plain English

Inclusion Criteria: 65-84 years old, BMI \< 30, at risk for functional decline based on SF-36, Instrumental Activities of Daily Living (per Nagy's), or 2 or more falls in prior 2 years Exclusion Criteria: Significant history or symptoms of acute medical conditions, currently in an exercise program, pain or other conditions that would prevent participating in exercise testing

Locations (12)

Pfizer Investigational Site

Palo Alto, California, United States

Pfizer Investigational Site

San Diego, California, United States

Pfizer Investigational Site

Hamden, Connecticut, United States

Outcomes

Primary Outcomes

Percent increase in lean (non fat) body mass.

Time frame: Measured by DXA at BL 3, 6, 12, and 24 months

Change in functional performance (speed to climb stairs, walking speed and feet walked in 6 min).

Time frame: Measured at BL, 3, 6, 12, and 24 months