Essential Hypertension

Phase 2

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: ACT-280778; Drug: Placebo; Drug: Amlodipine

• Registration Number: NCT01264692
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-21
• Study First Posted: 2010-12-22
• Study Start: 2011-02
• Primary Completion: 2012-01
• Study Completion: 2012-02
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A	ACT-280778	ACT-280778
Treatment B	Placebo	Placebo
Treatment C	Amlodipine	Amlodipine

Primary Outcome Measures

Name	Time	Method
Change in mean(c) trough(d) SiDBP	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 Outcome Measures

Name	Time	Method
Change in mean trough SiSBP.	Baseline to Day 28	Change from baseline to Day 28 (± 2 days) of Period 2 (Visit 7) in mean trough SiSBP.

Trial Locations

Locations (18)

Clinical Investigative Site 3001; 🇷🇸 Belgrade, Serbia

Clinical Investigative Site 3004; 🇷🇸 Belgrade, Serbia

Clinical Investigative Site 3000; 🇷🇸 Niska Banja, Serbia

Clinical Investigative Site 4002; 🇷🇸 Pancevo, Serbia

Clinical Investigative Site 1009; 🇮🇱 Holon, Israel

Clinical Investigative Site 4000; 🇮🇱 Afula, Israel

Clinical Investigative Site 1003; 🇮🇱 Ashkelon, Israel

Clinical Investigative Site 1004; 🇮🇱 Givatayim, Israel

Clinical Investigative Site 4001; 🇷🇸 Belgrade, Serbia

Clinical Investigative Site 1008; 🇮🇱 Beer Sheva, Israel

Clinical InvestigativeSite 3003; 🇷🇸 Belgrade, Serbia

Clinical Investigative Site 3002; 🇷🇸 Zemun, Serbia

Clinical Investigative Site 1000; 🇮🇱 Jerusalem, Israel

Clinical Investigative Site 1006; 🇮🇱 Nazareth, Israel

Clinical Investigative Site 1010; 🇮🇱 Tel Aviv, Israel

Clinical Investigative Site 1007; 🇮🇱 Nazareth, Israel

Clinical Investigative Site 1005; 🇮🇱 Safed, Israel

Clinical Investigative Site 1012; 🇮🇱 Tel-Hashomer, Israel