An interventional study of liebria and information brochure on hypertension in Hypertension, sponsored by Gaia AG. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Gaia AG · Not applicable, Interventional, and Treatment
Among 282 studies in Hypertension with a site in Germany — 30 open to participants now, 46 under way, 11 of them phase 3. Hypertension · Germany.
Among the 282 studies in Hypertension with a site in Germany, this one is the 104th largest by planned enrollment of the 250 interventional ones that give a count, is one of 6 that started in 2024, is one of 67 with no phase, reaches primary completion later than 15 of the 45 other live ones, and was the 256th registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 328 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →30 of the 282 studies in Hypertension with a site in Germany are open now, in 12 countries. Each count lists the studies.
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →282 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 6 started in 2024.
Median enrollment 200 across the 250 interventional studies, 120 across the 30 observational. Of the 219 that completed or were terminated, 81 (37%) have results posted.
200 of 282 have an industry lead sponsor. The 10 most frequent:
Gaia AG is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Gaia AG has 1 study filed under Hypertension — fewer than ten, so there is no comparison to draw.
20 of the studies in Hypertension with a site in Germany that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03683186Phase 3United TherapeuticsA Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | 2026-12 |
| NCT06948422Phase 3Eli Lilly and CompanyA Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening) | 2027-09 |
| NCT06948435Phase 3Eli Lilly and CompanyA Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1 | 2027-09 |
| NCT06952530Phase 3Eli Lilly and CompanyA Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL2 | 2027-09 |
| NCT03604198Corcept TherapeuticsExtension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | 2026-12 |
Among the 282 studies in Hypertension with a site in Germany, from their registry updates:
This clinical trial with 328 patients with primary hypertension aims to investigate the effectiveness of the self-guided digital application liebria for patients with primary hypertension.
This clinical trial with 328 patients with primary hypertension aims to investigate the effectiveness of the self-guided digital application liebria for patients with primary hypertension. Inclusion criteria are: age ≥ 18; presence of primary hypertension (confirmed by medical certificate or equivalent); unmedicated or with existing antihypertensive drug therapy (with stable dose in the past 6 weeks prior to study enrolment); last reported office-based systolic blood pressure (SBP) ≥ 140 mmHg followed by home-based SBP ≥ 135 mmHg; consent to participate. Exclusion criteria are: home-based SBP > 180 mmHg; > triple combination of antihypertensive medication; history of secondary hypertension (e.g., thyroid disease, kidney disease); pregnancy.
Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive access to liebria in addition to treatment as usual (TAU, n = 164), or to a control group, in which they will receive a relevant brochure from the Deutsche Hochdruckliga (German Hypertension League) in addition to TAU (n = 164). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e. g. cardiologist).
The primary endpoint will be home-based SBP, with 6 months post-allocation being the primary time point for assessment of effectiveness. Three months post-allocation will be used as an additional endpoint. Secondary endpoints will be patient activation, social and work-related functioning, medication adherence, home-based diastolic blood pressure (DBP), and pulse pressure.
Analysis of effectiveness of the intervention will be performed by ANCOVA of the primary endpoint and all secondary endpoints, in which the posttreatment scores will be compared between treatment groups (intervention group vs. control group), using the baseline scores of the respective outcome as a covariate.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of primary hypertension, confirmed by submission of a medical certificate or equivalent (e.g., informal letter signed by primary care physician); relevant ICD-10-GM diagnoses:
Exclusion Criteria:
Participants allocated to the intervention group will receive access to liebria in addition to treatment as usual (TAU). reviga is a digital health application designed for individuals with hypertension, accessible through a web browser. The application focuses on evidence-based psychological and psychotherapeutic methods combined with psychoeducation and health behavior change. Topics addressed by liebria include clarifying and strengthening motivation, training the parasympathetic nervous system, recognizing and overcoming obstacles, strengthening impulse control, development of an individualized day plan, and relapse prevention. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 360 days.
Behavioral: liebria
Participants allocated to the control group will receive a brochure from the Deutsche Hochdruckliga (German Hypertension League) in addition to TAU.
Other: information brochure on hypertension
Participants will receive access to the digital health intervention liebria in addition to TAU
Participants will receive an information brochure on hypertension
SBP (in mmHg)
The primary endpoint is SBP collected via home-based blood pressure measurement (HBPM) using a validated semi-automatic arm cuff device. HBPM will be performed according to the recommendations of the European Society of Hypertension.
Time frame: 6 months
Patient activation
Patient Activation Measure (PAM-13). Total score ranging from 0-100; higher scores mean higher activation (better outcome).
Time frame: 6 months
Social and work-related functioning
Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).
Time frame: 6 months
Adherence to medication
Rief Adherence Index (RAI). Total score ranging from 4-20; higher scores mean higher non-adherence (worse outcome).
Time frame: 6 months
DBP (in mmHg)
DBP is collected via home-based blood pressure measurement (HBPM) using a validated semi-automatic arm cuff device. HBPM will be performed according to the recommendations of the European Society of Hypertension.
Time frame: 6 months
Pulse pressure (in mmHg)
Pulse pressure (PP) is collected via home-based blood pressure measurement (HBPM) using a validated semi-automatic arm cuff device. HBPM will be performed according to the recommendations of the European Society of Hypertension.
Time frame: 6 months
Body Mass Index
weight in kilograms and height in meters will be assessed and combined to report BMI in kg/m\^2
Time frame: 6 months, 3 months
concomitant antihypertensive medication
number and dosage of concomitant antihypertensive medications (agents in section C of the Anatomical Therapeutic Chemical Classification System)
Time frame: 6 months, 3 months
24-hour average SBP (in mmHg)
A 24-hour ambulatory blood pressure measurement (ABPM) will be performed according to recommendations of the International Society of Cardiology: ABPM will be conducted using an FDA-cleared, CE-labeled wireless, non-invasive chest-patch sensor for 24-hour, with measurements four times an hour over 24-hours, resulting in a total of 96 possible measurements.
Time frame: 6 months, 3 months
24-hour average DBP (in mmHg)
A 24-hour ambulatory blood pressure measurement (ABPM) will be performed according to recommendations of the International Society of Cardiology: ABPM will be conducted using an FDA-cleared, CE-labeled wireless, non-invasive chest-patch sensor for 24-hour, with measurements four times an hour over 24-hours, resulting in a total of 96 possible measurements.
Time frame: 6 months, 3 months
24-hour average PP (in mmHg)
A 24-hour ambulatory blood pressure measurement (ABPM) will be performed according to recommendations of the International Society of Cardiology: ABPM will be conducted using an FDA-cleared, CE-labeled wireless, non-invasive chest-patch sensor for 24-hour, with measurements four times an hour over 24-hours, resulting in a total of 96 possible measurements.
Time frame: 6 months, 3 months
Daytime average SBP (in mmHg)
Daytime average SBP will be defined as the average of those ABPM measurements collected between 10:00 and 20:00, in agreement with the International Database of ABP in relation to Cardiovascular Outcome (IDACO) criteria for Europeans.
Time frame: 6 months, 3 months
Nighttime average SBP (in mmHg)
Nighttime average SBP will be defined as the average of those ABPM measurements collected between 0:00 and 06:00, in agreement with the IDACO criteria for Europeans
Time frame: 6 months, 3 months
SBP (in mmHg)
The primary endpoint is SBP collected via home-based blood pressure measurement (HBPM) using a validated semi-automatic arm cuff device. HBPM will be performed according to the recommendations of the European Society of Hypertension.
Time frame: 3 months
Patient activation
Patient Activation Measure (PAM-13). Total score ranging from 0-100; higher scores mean higher activation (better outcome).
Time frame: 3 months
Social and work-related functioning
Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).
Time frame: 3 months
Adherence to medication
Rief Adherence Index (RAI). Total score ranging from 4-20; higher scores mean higher non-adherence (worse outcome).
Time frame: 3 months
DBP (in mmHg)
DBP is collected via home-based blood pressure measurement (HBPM) using a validated semi-automatic arm cuff device. HBPM will be performed according to the recommendations of the European Society of Hypertension.
Time frame: 3 months
Pulse pressure (in mmHg)
Pulse pressure (PP) is collected via home-based blood pressure measurement (HBPM) using a validated semi-automatic arm cuff device. HBPM will be performed according to the recommendations of the European Society of Hypertension.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Jun 2026, 26 months after the start.
Of 95 industry-sponsored interventional studies with no phase under Hypertension, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 55. This study's planned 26 months is below that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Gaia AG