Phase 3
N=336
MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01307046 ↗Enrolled (actual)
336
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) — -8.7; -3.6 mmHg — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MK-0954A (Drug); Losartan (Drug); Placebo to MK-0954A (Drug); Placebo to losartan 100 mg (Drug); Placebo to losartan 50 mg (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) |
-8.7; -3.6 | <.001 sig |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event (AE) |
31.3; 26.5 | — |
| SECONDARY Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) |
-14.5; -5.4 | <.001 sig |
Summary
This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension participants who are not adequately controlled with losartan.
Eligibility Criteria
Inclusion criteria
- Participant has a diagnosis of essential hypertension.
- Participant is not treated with antihypertensive medication and meets protocol-specified blood pressure criteria.
- Participant is treated with single antihypertensive medication, and meets protocol-specified blood pressure criteria.
- Participant is being treated with up to dual oral antihypertensive medications, and will be able to discontinue the prior antihypertensive medication.
- Participant has no clinically meaningful findings to be disqualified from the study at the discretion of the investigator.
Exclusion criteria
- Regarding hypertension, participant is currently taking > 2 antihypertensive medications.
- Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-lotan or Preminent and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines)
- Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or a recent history within the last year of drug or alcohol abuse or dependence.
- Participant is pregnant or breastfeeding or expecting to conceive or has a positive pregnancy test at the screening visit.
- Participant is currently participating or has participated in a study with an investigational compound (except losartan at any doses) or device within 30 days of signing informed consent.
Data sourced from ClinicalTrials.gov (NCT01307046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.