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OpenTrials
Completed

NCT Number: NCT01264692

Essential Hypertension

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Investigative Site 4000, Afula, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACT-280778

Drug

10 mg once daily for 28 ± 2 days

Placebo

Drug

Placebo oral capsules matching ACT-280778

Amlodipine

Drug

10 mg once daily for 28 ± 2 days

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study 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

Acronym: REDUCE-1

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 22, 2010
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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