Essential Hypertension

Essential Hypertension Clinical Trial

— REDUCE-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264692
• Other study ID #: AC-067A201
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

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