Essential Hypertension

NCT ID: NCT01264692

Last Updated: 2018-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-02-29

Brief Summary

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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

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A

ACT-280778

Group Type EXPERIMENTAL

ACT-280778

Intervention Type DRUG

10 mg once daily for 28 ± 2 days

Treatment B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral capsules matching ACT-280778

Treatment C

Amlodipine

Group Type OTHER

Amlodipine

Intervention Type DRUG

10 mg once daily for 28 ± 2 days

Interventions

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ACT-280778

10 mg once daily for 28 ± 2 days

Intervention Type DRUG

Placebo

Placebo oral capsules matching ACT-280778

Intervention Type DRUG

Amlodipine

10 mg once daily for 28 ± 2 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kasra Shakeri-Nejad, MD, PhD

Role: STUDY_DIRECTOR

Actelion

Locations

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Clinical Investigative Site 4000

Afula, , Israel

Site Status

Clinical Investigative Site 1003

Ashkelon, , Israel

Site Status

Clinical Investigative Site 1008

Beersheba, , Israel

Site Status

Clinical Investigative Site 1004

Giv‘atayim, , Israel

Site Status

Clinical Investigative Site 1009

Holon, , Israel

Site Status

Clinical Investigative Site 1000

Jerusalem, , Israel

Site Status

Clinical Investigative Site 1006

Nazareth, , Israel

Site Status

Clinical Investigative Site 1007

Nazareth, , Israel

Site Status

Clinical Investigative Site 1005

Safed, , Israel

Site Status

Clinical Investigative Site 1010

Tel Aviv, , Israel

Site Status

Clinical Investigative Site 1012

Tel Litwinsky, , Israel

Site Status

Clinical Investigative Site 3001

Belgrade, , Serbia

Site Status

Clinical InvestigativeSite 3003

Belgrade, , Serbia

Site Status

Clinical Investigative Site 4001

Belgrade, , Serbia

Site Status

Clinical Investigative Site 3004

Belgrade, , Serbia

Site Status

Clinical Investigative Site 3000

Niška Banja, , Serbia

Site Status

Clinical Investigative Site 4002

Pančevo, , Serbia

Site Status

Clinical Investigative Site 3002

Zemun, , Serbia

Site Status

Countries

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Israel Serbia

Other Identifiers

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AC-067A201

Identifier Type: -

Identifier Source: org_study_id

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