Clinical trial NCT01264692: Essential Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Essential Hypertension
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2010-12-22
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in mean(c) trough(d) SiDBP
timeFrame: Baseline to day 28
Secondary outcomes:
measure: Change in mean trough SiSBP.
timeFrame: Baseline to Day 28
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Clinical Investigative Site 4000
city: Ashkelon
country: Israel
facility: Clinical Investigative Site 1003
city: Beer Sheva
country: Israel
facility: Clinical Investigative Site 1008
city: Givatayim
country: Israel
facility: Clinical Investigative Site 1004
city: Holon
country: Israel
facility: Clinical Investigative Site 1009
city: Jerusalem
country: Israel
facility: Clinical Investigative Site 1000
city: Nazareth
country: Israel
facility: Clinical Investigative Site 1006
city: Nazareth
country: Israel
facility: Clinical Investigative Site 1007
city: Safed
country: Israel
facility: Clinical Investigative Site 1005
city: Tel Aviv
country: Israel
facility: Clinical Investigative Site 1010
city: Tel-Hashomer
country: Israel
facility: Clinical Investigative Site 1012
city: Belgrade
country: Serbia
facility: Clinical Investigative Site 3001
city: Belgrade
country: Serbia
facility: Clinical InvestigativeSite 3003
city: Belgrade
country: Serbia
facility: Clinical Investigative Site 4001
city: Belgrade
country: Serbia
facility: Clinical Investigative Site 3004
city: Niska Banja
country: Serbia
facility: Clinical Investigative Site 3000
city: Pancevo
country: Serbia
facility: Clinical Investigative Site 4002
city: Zemun
country: Serbia
facility: Clinical Investigative Site 3002
Study officials:
affiliation: Actelion
name: Kasra Shakeri-Nejad, MD, PhD
role: STUDY_DIRECTOR
References: