Clinical trial NCT00888355: MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension
Official title: A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Losartan Given Once or Twice Daily in Patients With Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-04-27
Enrollment: 428
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
timeFrame: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)
Secondary outcomes:
measure: Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12
timeFrame: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)
measure: Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12
timeFrame: At baseline and at 12 weeks (6 hours after last morning dose)
measure: Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
timeFrame: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks
Other outcomes:
measure: Number of Patients With Clinical Adverse Experiences (CAEs)
timeFrame: 12 weeks
measure: Number of Patients With Serious CAEs
timeFrame: 12 weeks
measure: Number of Patients With Drug-related CAEs
timeFrame: 12 weeks
measure: Number of Patients Discontinued Due to CAEs
timeFrame: 12 weeks
measure: Number of Patients Who Died
timeFrame: 12 weeks
measure: Number of Patients With Laboratory Adverse Experiences (LAEs)
timeFrame: 12 weeks
measure: Number of Patients With Serious LAEs
timeFrame: 12 weeks
measure: Number of Patients With Drug-related LAEs
timeFrame: 12 weeks
measure: Number of Patients Discontinued Due to LAEs
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: