Essential Hypertension

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion; Idorsia Pharmaceuticals Ltd.
• Treatments: Amlodipine

Criteria

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