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Essential Hypertension (REDUCE-1)

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ACT-280778
Placebo
Amlodipine
Sponsored by
Idorsia Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical Investigative Site 4000
  • Clinical Investigative Site 1003
  • Clinical Investigative Site 1008
  • Clinical Investigative Site 1004
  • Clinical Investigative Site 1009
  • Clinical Investigative Site 1000
  • Clinical Investigative Site 1006
  • Clinical Investigative Site 1007
  • Clinical Investigative Site 1005
  • Clinical Investigative Site 1010
  • Clinical Investigative Site 1012
  • Clinical Investigative Site 3001
  • Clinical InvestigativeSite 3003
  • Clinical Investigative Site 4001
  • Clinical Investigative Site 3004
  • Clinical Investigative Site 3000
  • Clinical Investigative Site 4002
  • Clinical Investigative Site 3002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Treatment A

Treatment B

Treatment C

Arm Description

ACT-280778

Placebo

Amlodipine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2010
Last Updated
September 26, 2018
Sponsor
Idorsia Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01264692
Brief Title
Essential Hypertension
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idorsia Pharmaceuticals Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Experimental
Arm Description
ACT-280778
Arm Title
Treatment B
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Treatment C
Arm Type
Other
Arm Description
Amlodipine
Intervention Type
Drug
Intervention Name(s)
ACT-280778
Intervention Description
10 mg once daily for 28 ± 2 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral capsules matching ACT-280778
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
10 mg once daily for 28 ± 2 days
Primary Outcome Measure Information:
Title
Change in mean(c) trough(d) SiDBP
Description
Change from baseline(b) to Day 28 (± 2 days) of Period 2 (Visit 7)in mean(c) trough(d) SiDBP.
Time Frame
Baseline to day 28
Secondary Outcome Measure Information:
Title
Change in mean trough SiSBP.
Description
Change from baseline to Day 28 (± 2 days) of Period 2 (Visit 7) in mean trough SiSBP.
Time Frame
Baseline to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kasra Shakeri-Nejad, MD, PhD
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Investigative Site 4000
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Clinical Investigative Site 1003
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Clinical Investigative Site 1008
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Clinical Investigative Site 1004
City
Givatayim
ZIP/Postal Code
53583
Country
Israel
Facility Name
Clinical Investigative Site 1009
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Clinical Investigative Site 1000
City
Jerusalem
ZIP/Postal Code
91004
Country
Israel
Facility Name
Clinical Investigative Site 1006
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Clinical Investigative Site 1007
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Clinical Investigative Site 1005
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Clinical Investigative Site 1010
City
Tel Aviv
ZIP/Postal Code
66872
Country
Israel
Facility Name
Clinical Investigative Site 1012
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Clinical Investigative Site 3001
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical InvestigativeSite 3003
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Investigative Site 4001
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
Clinical Investigative Site 3004
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Investigative Site 3000
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Clinical Investigative Site 4002
City
Pancevo
ZIP/Postal Code
26000
Country
Serbia
Facility Name
Clinical Investigative Site 3002
City
Zemun
ZIP/Postal Code
11080
Country
Serbia

12. IPD Sharing Statement

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Essential Hypertension

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