Phase 4
Completed N=115
Study of Efficacy and Safety of CVAA489 in Hypertensive Patients
Source: ClinicalTrials.gov NCT02062645 ↗Enrolled (actual)
115
Serious AEs
2.7%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 — 47.0; 78.0; 45.0; 70.3 Percentage of Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The population that will be included in this study, will be regular Turkish hypertensive patients who are expected to consume sodium in high amounts. It is hypothesized that, in that population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP) control rate as expected from literature.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 |
47.0; 78.0; 45.0; 70.3; 82.4; 67.0 | — |
| SECONDARY Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8 |
164.3; 140.17; 134.04; 134.71; 24.15; 30.22 | — |
| SECONDARY Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8 |
96.66; 82.0; 81.04; 81.37; 14.66; 15.54 | — |
| SECONDARY Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 |
68.6; 64.1; 62.9 | — |
| SECONDARY SBP and DBP in Patients With High Sodium Intake at Week 4 and 8 |
140.01; 134.20; 134.84; 81.73; 81.23; 81.47 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, above 18 years of age
- Diagnosis of essential hypertension
- Newly diagnosed,
- Previously untreated, or Currently untreated (not on regular antihypertensive treatment during the previous at least 1-month period)
- Written informed consent
Exclusion Criteria
- Known or suspected secondary hypertension
- eGFR lower than 30 mL/min
- Use of any other hypertension treatments during the enrollment and need for using the related treatments during the study phase
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. (i.e. valsartan, amlodipine, hydrochlorothiazide)
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days until the expected PD effect has returned to baseline, whichever is longer.Pregnant or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02062645). 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.