Phase 3
N=327
MK-0954E Study in Participants With Hypertension (MK-0954E-357)
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01302691 ↗Enrolled (actual)
327
Serious AEs
0.6%
Results posted
Jan 2017
Primary outcome: Primary: Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) — -9.1; -8.0 mmHg — p=0.205
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E) (Drug); Losartan potassium (Drug); Amlodipine besylate (Drug); Placebo to MK-0954E (Drug); Placebo to losartan potassium (Drug); Placebo to amlodipine besylate (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) |
-9.1; -8.0 | 0.205 |
| PRIMARY Percentage of Participants Who Experience ≥1 Adverse Event (AE) |
30.5; 28.8 | — |
| PRIMARY Percentage of Participants Who Experience ≥1 Drug-related AE |
11.6; 3.7 | — |
| PRIMARY Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE) |
0.6; 0.6 | — |
| PRIMARY Percentage of Participants Who Experience ≥1 Drug-related SAE |
0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Had Study Drug Stopped Due to an AE |
1.2; 0.0 | — |
| SECONDARY Change in Mean Trough Sitting Systolic Blood Pressure (SiSBP) |
-13.4; -10.2 | 0.011 sig |
Summary
This study is being done to evaluate the efficacy, safety, and tolerability of losartan potassium 50 mg (L50) + hydrochlorothiazide 12.5 mg (H12.5) + amlodipine besylate 5 mg (A5) (MK-0954E). The primary hypothesis is that L50/H12.5/A5 is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to L50+A5 in Japanese participants with essential hypertension who are not adequately controlled following an 8-week treatment with filter period study drug (L50+A5).
Eligibility Criteria
Inclusion criteria
- Participant has a diagnosis of essential hypertension.
- Participant is being treated with single or dual treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
- Participant has a mean trough SiDBP of ≥ 90 mmHg and 2 antihypertensive medications.
- Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-Lotan or Preminent, amlodipine or dihydropyridine drug, 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 has had a recent history within the last year of drug or alcohol abuse or dependence.
- Participant is pregnant or breastfeeding, or expecting to conceive OR the pregnancy test is positive at screening visit (Visit 1).
- Participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
Data sourced from ClinicalTrials.gov (NCT01302691). 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.