Phase 3
N=278
A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01307033 ↗Enrolled (actual)
278
Serious AEs
1.9%
Results posted
Jan 2014
Primary outcome: Primary: Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension) — 71.0; 72.4 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MK-0954A (Drug); MK-954H (Drug); Placebo to MK-0954A (Drug); Placebo to MK-954H (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension) |
71.0; 72.4 | — |
| SECONDARY Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8 |
-5.3; -5.0 | — |
| SECONDARY Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8 |
-6.2; -8.5 | — |
Summary
This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).
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 >=90mmHg and =140mmHg and 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 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.
- 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 (NCT01307033). 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.