Trial · NCT05683301
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 | 24-hour ambulatory systolic Blood Pressure | Change in between baseline and 6 month Ambulatory Systolic Blood Pressure | To determine which of three single pill combinations of two anti-hypertensive agents is most effective in reducing 24-hour ambulatory systolic BP (ASBP) in Indian patients with hypertension. |
| Secondary | 24-hour ambulatory diastolic blood pressure | Change in between baseline and 6 month Ambulatory Diastolic Blood Pressure | To determine which of three single pill combinations of two antihypertensive agents is most effective in reducing 24-hour ambulatory diastolic blood pressure at 6 months adjusted for baseline ADBP |
| Secondary | Clinic Blood Pressure | Comparison of Clinic blood pressure measured at baseline 2 month , 4 month and 6 month | To determine which of three single pill combinations of two antihypertensive agents is most effective in reducing Clinic SBP and diastolic blood pressure (DBP) at two, four and six months adjusted for baseline values |
| Secondary | Daytime and nighttime Blood Pressure | Change in between baseline and 6 month ASBP and ADBP | To determine which of three single pill combinations of two antihypertensive agents is most effective in reducing Daytime and nighttime blood pressure (BP) a t six months adjusted for baseline values |
| Secondary | BP variability measured by ABPM and within-visit clinic BPs | Fluctuations in Ambulatory blood pressures as measured at baseline and 6 month and fluctuation in Clinic BP as measured at baseline, 2 month, 4 month and 6 month | To determine which of three single pill combinations of two antihypertensive agents is most effective in reducing 3.2.4. BP variability measured by ASBP and within-visit clinic BP |
| Secondary | Proportion of patients who achieve BP control | BP control measured in Clinic BP as measured at baseline, 2 month, 4 month and 6 month and ABP measured at baseline and 6 month | To determine which of the three single pill combinations of two antihypertensive agents is most effective in increasing the proportion of patients who achieve BP control defined as BP: \<140/90 mmHg and \<130/80mmHg at any of their clinic visits and maintained at the 6-month clinic visit. |
| Secondary | Proportion of patients classified as "responders" | Clinic BP as measured at baseline, 2 month, 4 month and 6 month | Proportion of patients classified as "responders" defined as those who had a reduction of SBP ≥20mmHg and DBP ≥10 mmHg at any of their clinic visits and maintained at the 6-month clinic visit. |
| Secondary | Micro- and macro-albuminuria | Change in serum albumin measured at baseline and 6 month | To determine the effect of three single pill combinations of two antihypertensive agents on Micro- and macro-albuminuria. |
| Secondary | Fasting blood glucose | Change in fasting blood glucose measured at baseline and 6 month | To determine the effect of three single pill combinations of two antihypertensive agents on Fasting blood glucose. |
| Secondary | Fasting lipid profile | Change in serum lipid profile measured at baseline and 6 month | To determine the effect of three single pill combinations of two antihypertensive agents on fasting lipid profile. |
| Secondary | Serum sodium | Change in serum sodium measured at baseline and 6 month | To determine the effect of three single pill combinations of two antihypertensive agents on serum sodium |
| Secondary | Serum potassium | Change in serum potassium measured at baseline and 6 month | To determine the effect of three single pill combinations of two antihypertensive agents on serum potassium |
| Secondary | Serum urea | Change in serum urea measured at baseline and 6 month | To determine the effect of three single pill combinations of two antihypertensive agents on serum urea |
| Secondary | Serum creatinine | Change in serum creatinine measured at baseline and 6 month | To determine the effect of three single pill combinations of two antihypertensive agents on serum creatinine |
| Secondary | eGFR | Change in eGFR measured at baseline and 6 month | To determine the effect of three single pill combinations of two antihypertensive agents on eGFR |
| Secondary | Adverse events causing trial withdrawal | adverse events causing withdrawal at 2 month, 4 month and 6 month | To determine the effect of three single pill combinations of two antihypertensive agents on adverse events causing trial withdrawal |
| Secondary | renin and aldosterone | Change in plasme renin and/or aldosterone measured at baseline and 6 month | To determine whether baseline plasma renin and/or aldosterone predicts any differential BP effects of the three single-pill combinations under investigation. |
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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