NCT01264692CompletedPhase 2
A Multi-center, Double-blind, Randomized, Placebo- and Active-controlled, Parallel-group, Proof-of-concept Study to Evaluate the Efficacy, Safety, and Tolerability of 10 mg of ACT-280778 in Patients With Mild to Moderate Essential Hypertension
Idorsia Pharmaceuticals Ltd.18 sites in 2 countries196 target enrollmentStarted: February 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Idorsia Pharmaceuticals Ltd.
- Enrollment
- 196
- Locations
- 18
- Primary Endpoint
- Change in mean(c) trough(d) SiDBP
Study Overview
Brief Summary
The purpose of this study is to demonstrate the antihypertensive efficacy of once daily oral administration of ACT 280778 on DBP compared to placebo after 28 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males and females aged 18 to 75 years (inclusive) at screening.
- •Body mass index (BMI) between 18 and 35 kg/m2 (inclusive) and body weight at least 50 kg at screening and prior to enrollment.
- •12-lead ECG without clinically relevant abnormalities measured at screening.
- •Clinical chemistry, hematology, coagulation, virus serology, and urinalysis test results not deviating to a clinically relevant extent from the normal range at screening.
- •Signed informed consent in the local language prior to any study-mandated procedure
Exclusion Criteria
- •Mean SBP > 180 mmHg.
- •Severe, malignant, or secondary hypertension.
- •Episodes of hypertensive crisis or hypertensive emergency within 6 months prior to enrollment.
- •Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions considered to be of clinical significance.
- •E6 Severe coronary artery disease indicated by myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft within the last 12 months prior to enrollment.
- •Angina pectoris within 6 months prior to enrollment
Arms & Interventions
Treatment A
Experimental
ACT-280778
Intervention: ACT-280778 (Drug)
Treatment B
Placebo Comparator
Placebo
Intervention: Placebo (Drug)
Treatment C
Other
Amlodipine
Intervention: Amlodipine (Drug)
Outcomes
Primary Outcomes
Change in mean(c) trough(d) SiDBP
Time Frame: Baseline to day 28
Change from baseline(b) to Day 28 (± 2 days) of Period 2 (Visit 7)in mean(c) trough(d) SiDBP.
Secondary Outcomes
- Change in mean trough SiSBP.(Baseline to Day 28)
Investigators
Study Sites (18)
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