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Angeliq

Phase 3

Hypertension | Small molecule | Cardiovascular |Bayer AG|Last Updated: Dec 31, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment750

FDA Designations

No designations recorded

Clinical trial landscape

Angeliq · 2 trials · 3 indications

Phase 3 2
NCT00651599Treatment of Vasomotor Symptoms in Korean Post Menopausal WomenVasomotor Symptoms
COMPLETED90 Analytics
NCT00102141Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive WomenHypertension
COMPLETED750 Analytics
PHASE3COMPLETED
Treatment of Vasomotor Symptoms in Korean Post Menopausal Women
Vasomotor SymptomsUnlock trial analytics
PHASE3COMPLETED
Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Hot flush (frequency and severity)
Daily in pre-treatment and treatment period
Mean change in systolic office blood pressure measured at through
After 8 weeks of treatment
Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM)
After 8 weeks of treatment

Secondary Endpoints

Menopausal symptoms
Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
Urogenital symptoms
Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment
Assessment of bleeding
daily in pre-treatment and treatment period
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 2PLACEBO_COMPARATOR -
Arm 1EXPERIMENTAL -
Arm 3EXPERIMENTAL -
Arm 4EXPERIMENTAL -
Arm 5PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)DRUGTreatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
PlaceboDRUGPlacebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
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Eligibility Criteria

Age Range45 Years to 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Postmenopausal Korean women suffering from hot flushes Exclusion Criteria: * Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagno...

Countries:South Korea
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Frequently asked questions about Angeliq

What is Angeliq used for?

Angeliq is a small molecule drug being developed by Bayer AG for the treatment of hypertension and vasomotor symptoms in postmenopausal women. It is currently in Phase 3 clinical development and is considered investigational, meaning it has not been approved for use.

Who makes Angeliq?

Angeliq is developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is being studied for cardiovascular and menopausal indications, including hypertension and vasomotor symptoms.

What phase is Angeliq in?

Angeliq is in Phase 3 clinical development. It has completed two Phase 3 trials, one in postmenopausal hypertensive women and another in Korean postmenopausal women with vasomotor symptoms. The drug remains investigational and is not yet approved.

What clinical trials is Angeliq in?

Angeliq has completed two Phase 3 trials. NCT00102141 studied its effect on blood pressure in 750 postmenopausal hypertensive women, and NCT00651599 evaluated treatment of vasomotor symptoms in 90 Korean postmenopausal women. Both trials were randomized, double-blind, and placebo-controlled.

Is Angeliq the same as any other drug?

Angeliq is a distinct drug product developed by Bayer AG. No alternative names have been associated with it in clinical trial records. It is being studied specifically for hypertension and vasomotor symptoms in postmenopausal women.