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NCT00749775: ESSENCE
Eplerenone Observational Study Of Safety And Efficacy Evaluation To Normalize Blood Pressure For Clinical Effectiveness
trial testing Selara in Hypertension in 3,338 participants. Completed in 1 December 2012.
1 December 2012
Quick facts
| Lead sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 3,338 |
| Start date | 1 June 2008 |
| Primary completion | 1 December 2012 |
| Estimated completion | 1 December 2012 |
Drugs / interventions tested
- Selara — full drug profile →
Conditions studied
- Hypertension — all drugs for Hypertension →
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. — full company profile →
Who can join
Eligibility, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Participants With Treatment Related Adverse Events.
Time frame: 12 weeks
Adverse events mean all unfavorable events that occur in participants after administration of Selara, irrespective of causal relationship to Selara (including clinically problematic abnormal changes in laboratory test values). Treatment Related Adverse Events were evaluated in company with the causal relationship to Selara. -
Number of Participants With Serious Treatment Related Adverse Events.
Time frame: 12 weeks
Serious treatment related adverse events mean those that may lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.
Sponsor's own description
To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00749775
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypertension
Currently open trials in the same condition.
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- NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
- NCT07238400 — Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia · Phase 2 · recruiting
- NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension · NA · recruiting
Other Pfizer's Upjohn has merged with Mylan to form Viatris Inc. trials
Trials by the same sponsor.
- NCT04391868 — A Bioequivalence Study of Sildenafil Citrate Orally-Disintegrating Film Dosage Form · Phase 1 · withdrawn
- NCT04176367 — An Bioequivalence Study Comparing Nicergoline 10 mg Tablet Manufactured in China With Nicergoline 10 mg Tablet Manufactu · Phase 1 · completed
- NCT03768726 — Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents · Phase 3 · terminated
- NCT03711708 — Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets · Phase 4 · completed
- NCT03342690 — Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure) · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00749775 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Last refreshed: 19 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00749775.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing