Non Interventional Study For Patients Treated With Somavert®

NCT00858143 | Completed Results DMC

• 1 other identifier: A6291014
• Study Type: observational
• Target: 311
• Locations: 0 countries
• Sites: N/A

Brief Summary

This open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study was performed in order to examine the efficacy and safety of Somavert® in treatment of subjects with acromegaly and its effects on acromegaly related co-morbidities.

Conditions

Acromegaly

Keywords

Open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Events (SAE) and Adverse Events (AE)

  Long term safety of Somavert in treatment of patients with acromegaly

  Baseline up to 5 years

Secondary Outcomes (45)

• Change From Baseline Insulin-like Growth Factor I (IGF-I)

  Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months

• IGF-I Values Within Normal Range

  Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

• IGF-I Values Above Normal Range

  Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

• Change From Baseline Hemoglobin A 1c (HbA 1c)

  Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

• HbA 1c Values Within Normal Range

  Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)

Study Arms (1)

1

Other: Non Interventional Observation

Interventions

Non Interventional Observation OTHER

Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.

You may qualify if:

• Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.

You may not qualify if:

• Subjects treated with an investigational drug for treatment of acromegaly.
• Subjects with symptoms such visual field loss, cranial nerve palsies or intracranial hypertension, indicating need for surgery.
• Women who were pregnant or lactating.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 9, 2009
• Study Start: January 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 2, 2009
• Results First Posted: August 12, 2009

Record last verified: 2009-03