Phase 3
N=286
MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356)
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01299376 ↗Enrolled (actual)
286
Serious AEs
1.6%
Results posted
Jan 2017
Primary outcome: Primary: Change in Trough Sitting Diastolic Blood Pressure (SiDBP)-Double-Blind Treatment Period — -12.1; -6.2 mmHg — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- L50/H12.5/A5 (Drug); L50/H12.5 (Drug); Placebo to L50/H12.5/A5 (Drug); Placebo to L50/H12.5 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Trough Sitting Diastolic Blood Pressure (SiDBP)-Double-Blind Treatment Period |
-12.1; -6.2 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Double-Blind Treatment Period |
27.0; 29.7 | — |
| PRIMARY Percentage of Participants Who Experience 1 or More Drug-Related AEs- Double-Blind Treatment Period |
12.1; 14.5 | — |
| PRIMARY Percentage of Participants Who Experience 1 or Serious Adverse Events (SAEs)- Double-Blind Treatment Period |
0.7; 1.4 | — |
| PRIMARY Percentage of Participants Who Experience 1 or More Drug-Related Serious Adverse Events (SAEs)- Double-Blind Treatment Period |
0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Had Study Drug Discontinued Due to an AE - Double Blind Treatment Period |
0.7; 1.4 | — |
| PRIMARY Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Long Term |
70.9; 66.2 | — |
| PRIMARY Percentage of Participants Who Experience 1 or More Drug-related AEs- Long Term |
27.7; 14.3 | — |
| PRIMARY Percentage of Participants Who Experience 1 or More SAEs- Long Term |
2.1; 3.0 | — |
| PRIMARY Percentage of Participants Who Experience 1 or More Drug-related SAEs- Long Term |
0.0; 0.8 | — |
| PRIMARY Percentage of Participants Who Had Study Drug Discontinued From the Study Due to an AE- Long Term |
2.1; 2.3 | — |
| SECONDARY Change in Trough Sitting Systolic Blood Pressure (SiSBP)-Double-Blind Treatment Period |
-17.7; -7.5 | <0.001 sig |
Summary
This study has two parts. In the first part, the efficacy and safety MK-0954E (losartan potassium 50 mg [L50] (+) hydrochlorothiazide 12.5 mg [H12.5] (+) amlodipine besylate 5mg [A5]) will be evaluated and compared to the efficacy and safety of MK-0954H (L50/H12.5) in Japanese participants. In the second part, the safety and tolerability of long-term use of open-label MK-0954E in participants with hypertension will be evaluated. The primary hypothesis is that MK-0954E is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to MK-954H (L50/H12.5 mg) in Japanese participants with essential hypertension who are not adequately controlled following a 8-week treatment with filter period study drug of MK-954H.
Eligibility Criteria
Inclusion criteria
- Participant has a diagnosis of essential hypertension
- Participant is being treated with a single, or dual combination 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 (NCT01299376). 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.