NCT00888355

Brief Summary

The study had a 4 week single blind placebo period followed by 12 weeks of double blind treatment. Patients were randomized to one of four treatment arms to evaluate the antihypertensive efficacy of Losartan.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
428

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started May 1992

Shorter than P25 for phase_3 hypertension

Status
completed

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

May 1, 1992

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1993

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 1993

Completed
16.2 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
2 months until next milestone

Results Posted

Study results publicly available

June 24, 2009

Completed
Last Updated

July 9, 2009

Status Verified

July 1, 2009

Enrollment Period

8 months

First QC Date

April 24, 2009

Results QC Date

May 7, 2009

Last Update Submit

July 2, 2009

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12

    Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12

    At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)

Secondary Outcomes (3)

  • Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12

    At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)

  • Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12

    At baseline and at 12 weeks (6 hours after last morning dose)

  • Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12

    24 hours after last morning dose and 12 hours after last PM dose at 12 weeks

Other Outcomes (9)

  • Number of Patients With Clinical Adverse Experiences (CAEs)

    12 weeks

  • Number of Patients With Serious CAEs

    12 weeks

  • Number of Patients With Drug-related CAEs

    12 weeks

  • +6 more other outcomes

Study Arms (4)

1

PLACEBO COMPARATOR

Placebo

Drug: Comparator: placebo

2

EXPERIMENTAL

Losartan 50 q.a.m.

Drug: losartan potassium

3

EXPERIMENTAL

Losartan 25 b.i.d.

Drug: losartan potassium

4

EXPERIMENTAL

Losartan 25 q.a.m.

Drug: losartan potassium

Interventions

losartan potassiumDRUG

losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks

Also known as: MK0954
234
Comparator: placeboDRUG

placebo to losartan tablet q.a.m. , for 12 weeks

1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has been diagnosed with mild to moderate hypertension
  • Patient has no treatment or active medical problem, other than hypertension that might affect the patients blood pressure

You may not qualify if:

  • Pregnant of lactating female patients
  • Secondary hypertension or history of malignant hypertension
  • Sitting systolic blood pressure \> 210 mmHg
  • History of stroke
  • History of myocardial infarction with in the past year
  • Current of prior history of heart failure
  • Known hypersensitivity to losartan
  • Obesity
  • Patients known to be HIV positive or known to be positive for Hepatitis B
  • Absence of one kidney
  • Patient is abusing or previously abused alcohol or drugs with in past two years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Losartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Limitations and Caveats

Note that deaths are not entered under "drop reasons" in the participant flow panel because the patients who died are already counted as dropped due to adverse event.

Results Point of Contact

Title
Executive Vice President, Clinical and Quantitative Sciences
Organization
Merck & Co., Inc.
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

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

April 24, 2009

First Posted

April 27, 2009

Study Start

May 1, 1992

Primary Completion

January 1, 1993

Study Completion

February 1, 1993

Last Updated

July 9, 2009

Results First Posted

June 24, 2009

Record last verified: 2009-07