Essential Hypertension (REDUCE-1)

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Essential Hypertension

Treatments: Drug: Placebo; Drug: ACT-280778; Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01264692

AC-067A201

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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196 participants in 3 patient groups, including a placebo group

Treatment A

Experimental group

Description:

ACT-280778

Treatment:

Drug: ACT-280778

Treatment B

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Treatment C

Other group

Description:

Amlodipine

Treatment:

Drug: Amlodipine