NCT00449111

Brief Summary

Evaluate blood pressure after 6 weeks of treatment with COZAAR plus.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_3 hypertension

Status
terminated

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

March 13, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2007

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

March 16, 2007

Last Update Submit

August 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of diastolic blood pressure after 6 weeks of treatment with cozaar plus

Interventions

Eligibility Criteria

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

You may qualify if:

  • Patient treated with valsartan 80mg or irbesartan 150mg or vandesartan 8mg for at least 4 weeks prior to visit 1
  • Patient with systolic blood pressure between 140 to 159 mmhg and diastolic pressure between 90 to 99mmhg taken at visit 1

You may not qualify if:

  • History of angina pectoris that has not been stabilized in the past 6 weeks
  • History of clinically significant abnormal lab results or diseases
  • Myocardial infarction within the past 6 months
  • Stroke in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

LosartanDuration of Therapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2007

First Posted

March 19, 2007

Study Start

March 13, 2006

Primary Completion

September 30, 2006

Study Completion

September 30, 2006

Last Updated

August 15, 2024

Record last verified: 2022-02