Essential Hypertension (REDUCE-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01264692
First received: December 20, 2010
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Essential Hypertension
Drug: ACT-280778
Drug: Placebo
Drug: Amlodipine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Change in mean(c) trough(d) SiDBP [ Time Frame: Baseline to day 28 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
    Change from baseline to Day 28 (± 2 days) of Period 2 (Visit 7) in mean trough SiSBP.


Enrollment: 196
Study Start Date: February 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
ACT-280778
Drug: ACT-280778
10 mg once daily for 28 ± 2 days
Placebo Comparator: Treatment B
Placebo
Drug: Placebo
Placebo oral capsules matching ACT-280778
Treatment C
Amlodipine
Drug: Amlodipine
10 mg once daily for 28 ± 2 days

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264692

Locations
Israel
Clinical Investigative Site 4000
Afula, Israel, 18101
Clinical Investigative Site 1003
Ashkelon, Israel, 78278
Clinical Investigative Site 1008
Beer Sheva, Israel, 84101
Clinical Investigative Site 1004
Givataim, Israel, 53583
Clinical Investigative Site 1009
Holon, Israel, 58100
Clinical Investigative Site 1000
Jerusalem, Israel, 91004
Clinical Investigative Site 1006
Nazareth, Israel, 16100
Clinical Investigative Site 1007
Nazareth, Israel, 16100
Clinical Investigative Site 1005
Safed, Israel, 13100
Clinical Investigative Site 1010
Tel Aviv, Israel, 66872
Clinical Investigative Site 1012
Tel-Hashomer, Israel, 52621
Serbia
Clinical Investigative Site 3001
Belgrade, Serbia, 11000
Clinical Investigative Site 4001
Belgrade, Serbia, 11040
Clinical Investigative Site 3004
Belgrade, Serbia, 11080
Clinical InvestigativeSite 3003
Belgrade, Serbia, 11000
Clinical Investigative Site 3002
Beograd-Zemun, Serbia, 11080
Clinical Investigative Site 3000
Niska Banja, Serbia, 18205
Clinical Investigative Site 4002
Pancevo, Serbia, 26000
Sponsors and Collaborators
Actelion
Investigators
Study Director: Kasra Shakeri-Nejad, MD, PhD Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01264692     History of Changes
Other Study ID Numbers: AC-067A201
Study First Received: December 20, 2010
Last Updated: June 12, 2012
Health Authority: Israel: Ethics Committees
Israel: Israeli Health Ministry Pharmaceutical Administration
Serbia: Medicines and Medical Devices Agency of Serbia
Serbia: Ethics Committee

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on April 16, 2014