NCT00679653

Brief Summary

To study the effect of sibutramine treatment on weight reduction and blood pressure improvement in three groups with antihypertensive therapy whose blood pressure was not adequately controlled with antihypertensive combination treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P25-P50 for phase_3 obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 19, 2008

Completed
Last Updated

May 19, 2008

Status Verified

May 1, 2008

Enrollment Period

1.8 years

First QC Date

March 26, 2008

Last Update Submit

May 16, 2008

Conditions

ObesityHypertension

Outcome Measures

Primary Outcomes (2)

  • Systolic Blood Pressure

    Duration of Study

  • Diastolic Blood Pressure

    Duration of Study

Study Arms (3)

1

ACTIVE COMPARATOR

verapamil/trandolapril

Drug: sibutramineDrug: verapamil/trandolapril

2

ACTIVE COMPARATOR

metoprolol/HCT

Drug: sibutramineDrug: metoprolol/HCT

3

ACTIVE COMPARATOR

felodipine/ramipril

Drug: sibutramineDrug: felodipine/ramipril

Interventions

sibutramineDRUG

8-wks, sibutramine, 10 mg, capsules, once daily

Also known as: ABT-991, Meridia, Reductil
123
verapamil/trandolaprilDRUG

2 wk Run-in phase, antihypertensive therapy only

1
metoprolol/HCTDRUG

2 wk Run-in phase, antihypertensive therapy only

2
felodipine/ramiprilDRUG

2 wk Run-in phase, antihypertensive therapy only

3

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Treated essential hypertension.
  • Obesity: BMI 27-35 kg/m2

You may not qualify if:

  • Secondary hypertension.
  • Stage 3 hypertension.
  • Secondary obesity; BMI \> 35kg/m2.
  • CAD; MI within past 6 months; NYHA stage 3 or 4 heart failure; tachyarrhythmia/atrial fibrillation; myocarditis.
  • Kidney failure.
  • Liver failure.
  • Hyperthyroidism.
  • Unstable DM.
  • Carcinoma.
  • Severe chronic infectious disease.
  • Alcohol or drug abuse.
  • Pregnancy.
  • Epilepsy.
  • Psychosis or treatment with antidepressants or major tranquilizers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityHypertension

Interventions

sibutramineVerapamiltrandolaprilFelodipineRamipril

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic ChemicalsDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2008

First Posted

May 19, 2008

Study Start

February 1, 2002

Primary Completion

December 1, 2003

Last Updated

May 19, 2008

Record last verified: 2008-05