Essential Hypertension (REDUCE-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01264692
Recruitment Status : Completed
First Posted : December 22, 2010
Last Update Posted : June 13, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: ACT-280778 Drug: Placebo Drug: Amlodipine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Amlodipine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment A
Drug: ACT-280778
10 mg once daily for 28 ± 2 days
Placebo Comparator: Treatment B
Drug: Placebo
Placebo oral capsules matching ACT-280778
Treatment C
Drug: Amlodipine
10 mg once daily for 28 ± 2 days

Primary Outcome Measures :
  1. Change in mean(c) trough(d) SiDBP [ Time Frame: Baseline to day 28 ]
    Change from baseline(b) to Day 28 (± 2 days) of Period 2 (Visit 7)in mean(c) trough(d) SiDBP.

Secondary Outcome Measures :
  1. Change in mean trough SiSBP. [ Time Frame: Baseline to Day 28 ]
    Change from baseline to Day 28 (± 2 days) of Period 2 (Visit 7) in mean trough SiSBP.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01264692

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
Clinical Investigative Site 3001
Belgrade, Serbia, 11000
Clinical InvestigativeSite 3003
Belgrade, Serbia, 11000
Clinical Investigative Site 4001
Belgrade, Serbia, 11040
Clinical Investigative Site 3004
Belgrade, Serbia, 11080
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
Study Director: Kasra Shakeri-Nejad, MD, PhD Actelion

Responsible Party: Actelion Identifier: NCT01264692     History of Changes
Other Study ID Numbers: AC-067A201
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents