Obese Hypertension Study (0954-315)

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00289887
• Lead Sponsor: Organon and Co

Brief Summary

This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-08
• Study First Submitted QC: 2006-02-08
• Study First Posted: 2006-02-10
• Primary Completion: 2007-02
• Study Completion: 2007-03
• Results First Submitted: 2009-09-21
• Results First Submitted QC: 2010-04-29
• Results First Posted: 2010-05-27
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

• Obese male and female patients, ages 21-75 years, with high blood pressure

Exclusion Criteria

• Patients cannot have any other severe cardiac conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12	At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)	Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12.; A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12	At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)	Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12.; A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8	At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)	Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8.; A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8	At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)	Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8.; A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16	At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)	Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16.; A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16	At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)	Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16.; A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment\*week, and week\*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline.