N/A
Completed N=2,092
Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients
Source: ClinicalTrials.gov NCT01853839 ↗Enrolled (actual)
2,092
Serious AEs
1.0%
Results posted
Aug 2015
Primary outcomePrimary: Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52 — 94.95; 5.05 Percentage of participants
Summary
This is an out-patient based prospective, multi-centre, observational post-marketing surveillance study amongst internists and cardiologists. In this study, patients with essential hypertension and at least one additional risk factor will be included. Patients may take any antihypertensive treatment which is approved for cardiovascular protection including Micardis 80 mg / Micardis Plus. Patients will be followed over one year in four visits from baseline to endpoint with an additional visit before and after the month of Ramadan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52 |
94.95; 5.05 | — |
| SECONDARY Achieving JNC 7 Treatment Goals After Ramadan |
87.07; 85.97; 12.93; 14.02 | — |
| SECONDARY Cardiovascular Events |
0.91 | — |
| SECONDARY The Overall Assessment of Treatment by Patients at 52 Weeks |
25.45; 53.88; 18.80; 1.42; 0.45 | — |
| SECONDARY The Overall Assessment of Treatment by Physicians at 52 Weeks |
25.97; 55.49; 16.21; 1.74; 0.58 | — |
| SECONDARY Compliance of Patients up to 10 Days Before Ramadan |
70.58; 25.45; 0.95; 1.06; 1.96 | — |
| SECONDARY Compliance of Patients up to 10 Days After Ramadan |
71.11; 24.37; 2.40; 0.80; 1.32 | — |
| SECONDARY Compliance of Patients During the Whole Study Duration (52 Weeks) |
70.68; 25.78; 1.98; 0.48; 1.08 | — |
| SECONDARY Achievement of the JNC 7 Treatment Goals During the Whole Study Duration (Treated by Internists and Cardiologists as Primary Physician) |
96.64; 93.98; 3.36; 6.02 | — |
| SECONDARY The Difference in Systolic Blood Pressure Before and After the Month of Ramadan |
24.4; 25.0; 28.3; 29.3; 30.3; 30.6 | — |
| SECONDARY The Difference in Diastolic Blood Pressure Before and After the Month of Ramadan |
12.2; 12.5; 14.4; 15.1; 15.5; 16.2 | — |
| SECONDARY The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration |
85.93; 14.07 | — |
| SECONDARY Adverse Events Under Angiotensin II (Type 1) Receptor Blockers (ARBs) Treatment When Given in Combination With Calcium-Channel Blockers (CCBs) |
27 | — |
Eligibility Criteria
Inclusion criteria
- Male or female of age 18 years or older;
- Newly diagnosed and untreated or previously treated and uncontrolled patients with essential hypertension;
- Seated blood pressure of >140/90 mmHg or >130/80 mmHg in patients with diabetes mellitus or chronic kidney disease;
- Patients with at least one cardiovascular (cv) risk factor;
- Ability to provide written informed consent.
Exclusion criteria
- Patients with contraindications to the prescribed antihypertensive medications;
- Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception;
- Patients who are participating in any other study protocol.
Data sourced from ClinicalTrials.gov (NCT01853839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.