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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01264692
Other study ID # AC-067A201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2011
Est. completion date February 2012

Study information

Verified date September 2018
Source Idorsia Pharmaceuticals Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date February 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
ACT-280778
10 mg once daily for 28 ± 2 days
Placebo
Placebo oral capsules matching ACT-280778
Amlodipine
10 mg once daily for 28 ± 2 days

Locations

Country Name City State
Israel Clinical Investigative Site 4000 Afula
Israel Clinical Investigative Site 1003 Ashkelon
Israel Clinical Investigative Site 1008 Beer Sheva
Israel Clinical Investigative Site 1004 Givatayim
Israel Clinical Investigative Site 1009 Holon
Israel Clinical Investigative Site 1000 Jerusalem
Israel Clinical Investigative Site 1006 Nazareth
Israel Clinical Investigative Site 1007 Nazareth
Israel Clinical Investigative Site 1005 Safed
Israel Clinical Investigative Site 1010 Tel Aviv
Israel Clinical Investigative Site 1012 Tel-Hashomer
Serbia Clinical Investigative Site 3001 Belgrade
Serbia Clinical Investigative Site 3004 Belgrade
Serbia Clinical Investigative Site 4001 Belgrade
Serbia Clinical InvestigativeSite 3003 Belgrade
Serbia Clinical Investigative Site 3000 Niska Banja
Serbia Clinical Investigative Site 4002 Pancevo
Serbia Clinical Investigative Site 3002 Zemun

Sponsors (1)

Lead Sponsor Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

Israel,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in mean(c) trough(d) SiDBP Change from baseline(b) to Day 28 (± 2 days) of Period 2 (Visit 7)in mean(c) trough(d) SiDBP. Baseline to day 28
Secondary Change in mean trough SiSBP. Change from baseline to Day 28 (± 2 days) of Period 2 (Visit 7) in mean trough SiSBP. Baseline to Day 28
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