Phase 3
Completed N=327
MK-0954E Study in Participants With Hypertension (MK-0954E-357)
Source: ClinicalTrials.gov NCT01302691 ↗Enrolled (actual)
327
Serious AEs
0.6%
Results posted
Jan 2017
Primary outcomePrimary: Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) — -9.1; -8.0 mmHg — p=0.205
◆ Published Evidence
Emerging
12citations · ~1 / year
Add-on effect of hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension uncontrolled with losartan 50 mg and amlodipine 5 mg.
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).
Linked Publications (2)
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Add-on effect of hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension uncontrolled with losartan 50 mg and amlodipine 5 mg.
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Efficacy and safety of fixed-dose losartan/hydrochlorothiazide/amlodipine combination versus losartan/hydrochlorothiazide combination in Japanese patients with essential hypertension.
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 |
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) and the linked publication. 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. Informational only — not medical advice.