NCT01264692

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_2

Geographic Reach
2 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

December 20, 2010

Last Update Submit

September 26, 2018

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in mean trough SiSBP.

    Baseline to Day 28

Study Arms (3)

Treatment A

EXPERIMENTAL

ACT-280778

Drug: ACT-280778

Treatment B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Treatment C

OTHER

Amlodipine

Drug: Amlodipine

Interventions

ACT-280778DRUG

10 mg once daily for 28 ± 2 days

Treatment A
PlaceboDRUG

Placebo oral capsules matching ACT-280778

Treatment B
AmlodipineDRUG

10 mg once daily for 28 ± 2 days

Treatment C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Clinical Investigative Site 4000

Afula, 18101, Israel

Location

Clinical Investigative Site 1003

Ashkelon, 78278, Israel

Location

Clinical Investigative Site 1008

Beersheba, 84101, Israel

Location

Clinical Investigative Site 1004

Giv‘atayim, 53583, Israel

Location

Clinical Investigative Site 1009

Holon, 58100, Israel

Location

Clinical Investigative Site 1000

Jerusalem, 91004, Israel

Location

Clinical Investigative Site 1006

Nazareth, 16100, Israel

Location

Clinical Investigative Site 1007

Nazareth, 16100, Israel

Location

Clinical Investigative Site 1005

Safed, 13100, Israel

Location

Clinical Investigative Site 1010

Tel Aviv, 66872, Israel

Location

Clinical Investigative Site 1012

Tel Litwinsky, 52621, Israel

Location

Clinical Investigative Site 3001

Belgrade, 11000, Serbia

Location

Clinical InvestigativeSite 3003

Belgrade, 11000, Serbia

Location

Clinical Investigative Site 4001

Belgrade, 11040, Serbia

Location

Clinical Investigative Site 3004

Belgrade, 11080, Serbia

Location

Clinical Investigative Site 3000

Niška Banja, 18205, Serbia

Location

Clinical Investigative Site 4002

Pančevo, 26000, Serbia

Location

Clinical Investigative Site 3002

Zemun, 11080, Serbia

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

isobutyric acid 2-(2-((3-(4,7-dimethoxy-1H-benzoimidazol-2-yl)propyl)methylamino)ethyl)-5-phenylbicyclo(2.2.2)oct-5-en-2-yl esterAmlodipine

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kasra Shakeri-Nejad, MD, PhD

    Actelion

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2010

First Posted

December 22, 2010

Study Start

February 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

September 27, 2018

Record last verified: 2018-09

Locations

IL(11)SE(7)