Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT01625494
Brief Summary:
Primary Objective:
\- To assess the proportion of patients with controlled Office Blood Pressure Measurements (OBPM), defined as Systolic blood pressure \< 140 mmHg and Diastolic blood pressure \<90mmHg, at the end of the study
Secondary Objectives:
* To examine over time the antihypertensive effect of the 4 doses of the fixed combination therapy irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and DBP (diastolic blood pressure)
* To examine the proportion of patients with controlled OBPM (systolic BP\<140 mm Hg and diastolic BP\<90 mmHg) of the different dose groups over time
* To determine the incidence and severity of adverse events.
Detailed Description:
16 weeks
* V1 (week 0): Inclusion visit.
* V2 (Week 4): Irbesartan/amlodipine 150/5 mg fixed combination visit
* V3 (Week 8): 1st dose escalation for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg,
* V4 (Week 12): 2nd Dose escalation visit for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg
* V5 (Week 16): End of study visit
Study:
NCT01625494
Study Brief:
Protocol Section:
NCT01625494