Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India
- Conditions
- Primary Hypertension
- Registration Number
- NCT05683301
- Lead Sponsor
- Centre for Chronic Disease Control, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Age 30-79 years AND<br><br> 2. Sitting clinic values* of SBP =140 mmHg and <160 mmHg on one antihypertensive agent<br> OR<br><br> 3. Sitting clinic values* of SBP =150 mmHg and <180 mmHg on no antihypertensive<br> treatment * Mean of the last 2 of 3 readings.<br><br>Exclusion Criteria:<br><br> 1. Congestive heart failure (clinically defined).<br><br> 2. Patients with a history of intolerance to any of the study medications for example<br> angioedema or dry cough with Angiotensin-converting enzyme inhibitors.<br><br> 3. Serum creatinine levels greater than 132.6µmol/l (1.5mg/dl)<br><br> 4. <br><br> 4. History of coronary heart disease (i.e., chronic stable angina, myocardial<br> infarction or acute coronary syndrome).<br><br> 5. History of a stroke or other cerebrovascular accident (i.e. transient ischaemic<br> attack or reversible ischaemic neurological deficit).<br><br> 6. Severe hepatic impairment<br><br> 7. Treatment with agents causing torsades de pointes<br><br> 8. Lactation<br><br> 9. Contraindications to any of the investigational medicinal products as per the<br> summaries product characteristics of drugs studied<br><br> 10. Known or suspected secondary hypertension.<br><br> 11. Any other concomitant illness, physical or mental impairment that could interfere<br> with the effective conduct of the study.<br><br> 12. Pregnancy or those of child-bearing age who are not taking reliable contraception.<br><br> 13. History of Gout.<br><br> 14. Serum potassium < 3.5mmol/L at screening.<br><br>
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 24-hour ambulatory systolic Blood Pressure
- Secondary Outcome Measures
Name Time Method 24-hour ambulatory diastolic blood pressure;Clinic Blood Pressure;Daytime and nighttime Blood Pressure;BP variability measured by ABPM and within-visit clinic BPs;Proportion of patients who achieve BP control;Proportion of patients classified as responders;Micro- and macro-albuminuria;Fasting blood glucose;Fasting lipid profile;Serum sodium;Serum potassium;Serum urea;Serum creatinine;eGFR;Adverse events causing trial withdrawal;renin and aldosterone