NCT00656331

Brief Summary

The purpose of this study is to compare the effects of the cholesterol medication taken with each blood pressure medication alone on heart disease risk factors including blood pressure, cholesterol, inflammation, blood sugar control, blood vessal function, and other heart disease risk factors.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

6.8 years

First QC Date

April 7, 2008

Last Update Submit

July 7, 2023

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • PAI-1

    study completion

Study Arms (2)

1

ACTIVE COMPARATOR

Amlodipine

Drug: Amlodipine and Hydrocholorothiazide

2

ACTIVE COMPARATOR

HCTZ

Drug: Amlodipine and Hydrocholorothiazide

Interventions

Amlodipine and HydrocholorothiazideDRUG

Arm 1 gets Amlodipine and Arm 2 gets Hydrocholorothiazide

12

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mild hypertension and high cholesterol

You may not qualify if:

  • diabetes and heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNMHSC

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kathleen Colleran, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 11, 2008

Study Start

August 1, 2005

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 11, 2023

Record last verified: 2023-07

Locations

US(1)