Trial · NCT04308590
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Average 24-hour SBP | Baseline and Week 22 | Blood pressure was measured by 24-hour ABPM. The 24-hour average SBP is reported. |
| Primary | Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. | Baseline and up to Week 26 | |
| Secondary | Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) | Before and at time intervals up to 2 hours post glucose drink at Baseline and Week 22 | AUCglucose was calculated based on results of the plasma 2-hour oGTT. |
| Secondary | Change in Average Diastolic Blood Pressure (DBP) | Baseline and Week 22 | Blood pressure was measured by 24-hour ABPM. Daytime average DBP was measured from 06:00 to 21:59. Nighttime average DBP was measure from 22:00 to 05:59. |
| Secondary | Change in Average Heart Rate (HR) | Baseline and Week 22 | Heart rate was measured by 24-hour ABPM. Daytime average HR was measured from 06:00 to 21:59. Nighttime average HR was measure from 22:00 to 05:59. |
| Secondary | Change in Average Daytime and Nighttime SBP | Baseline and Week 22 | Blood pressure was measured by 24-hour ABPM. Daytime average SBP was measured from 06:00 to 21:59. Nighttime average SBP was measure from 22:00 to 05:59. |
| Secondary | Change in Hemoglobin HbA1c for Patients With HbA1c ≥5.7% at Baseline | Baseline and Week 22 | |
| Secondary | Change in HbA1c for Patients With HbA1c ≥6.5% at Baseline | Baseline and Week 22 | |
| Secondary | Number of Patients With DM Who Achieved 2-hour oGTT Glucose <140 mg/dL | 2 hours post glucose drink at Week 22 | Glucose was measured using the 2 hour timepoint of the 2-hour oGTT. |
| Secondary | Number of Patients With IGT Who Achieved 2-hour oGTT Glucose <140 mg/dL | 2 hours post glucose drink at Week 22 | Glucose was measured using the 2 hour timepoint of the 2-hour oGTT. |
| Secondary | Number of Patients With Any Dose Decrease in Antihypertensive Medication | Baseline and Week 22 | |
| Secondary | Number of Patients With Any Dose Decrease in Diabetes Medication | Baseline and Week 22 | |
| Secondary | Number of Patients With Any Dose Increase or Switch in Antihypertensive Medication | Baseline and Week 22 | |
| Secondary | Number of Patients With Any Dose Increase or Switch in Diabetes Medication | Baseline and Week 22 | |
| Secondary | Number of Patients With HbA1c ≥6.5% at Baseline Who Achieved HbA1c <6.5% | Baseline and Week 22 | |
| Secondary | Number of Patients With Normalization of the 24-hour Average SBP (<130 mm Hg) | Baseline and Week 22 | Blood pressure was measured by 24-hour ABPM Test. Reported is the number of patients with HTN at Baseline who achieved SBP \<130 mm Hg at Week 22. |
| Secondary | Number of Patients With a Reduction in 24-hour Average SBP by ≥5 mm Hg | Baseline and Week 22 | Blood pressure was measured by 24-hour ABPM. Reported is the number of patients with HTN at Baseline who achieved at least a 5 mm Hg reduction in 24-hour average SBP at Week 22. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT04308590/registered